Ebi, LLC
Parsippany, NJ, US
EBI, LLC appears in FDA device records in Parsippany, NJ. FDA records list 99 510(k) clearances between and , 6 PMA records and one registered establishment. As of , FDA records show 61 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
Showing 50 of 99FDA records hold 99 510(k) clearances for Ebi, LLC between 1997 and 2014. The busiest year on record is 2002, with 19. The most recent is 2014, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1997 | 1 |
| 1999 | 5 |
| 2000 | 8 |
| 2001 | 14 |
| 2002 | 19 |
| 2003 | 14 |
| 2004 | 9 |
| 2005 | 3 |
| 2006 | 10 |
| 2007 | 1 |
| 2008 | 1 |
| 2009 | 6 |
| 2010 | 4 |
| 2011 | 1 |
| 2012 | 1 |
| 2014 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K140734 | NEXTGEN ALTIUS OCT SYSTEM | KWP | Substantially Equivalent | |
| K140123 | POLARIS SPINAL SYSTEM -TRANSLATION SCREW | NKB | Substantially Equivalent | |
| K113796 | SOLITAIRE-C CERVICAL SPACER SYSTEM | OVE | Substantially Equivalent | |
| K111376 | CONSTRUX EXTERNAL FIXATION DEVICE | KTT | Substantially Equivalent | |
| K100438 | POLARIS SPINAL SYSTEM, POLARIS/SYNERGY STRUCTURE ANTERIOR FIXATION SYSTEM | NKB | Substantially Equivalent | |
| K100220 | POLARIS SPINAL SYSTEM | NKB | Substantially Equivalent | |
| K093880 | PEANUT GROWTH CONTROL PLATING SYSTEM | HRS | Substantially Equivalent | |
| K092574 | ESL SPINAL SYSTEM | MAX | Substantially Equivalent | |
| K093057 | BIOMET VISION FOOTRING SYSTEM | KTT | Substantially Equivalent | |
| K092336 | C-THRU SPINAL SYSTEM | MQP | Substantially Equivalent | |
| K091381 | IBEX SPINAL SYSTEM | MAX | Substantially Equivalent | |
| K090203 | 5.5 HELICAL FLANGE SPINAL SYSTEM, POLARIS COMPONENTS | NKB | Substantially Equivalent | |
| K090523 | POLARIS SPINAL SYSTEM | NKB | Substantially Equivalent | |
| K082406 | EXPANDABLE PEEK-OPTIMA IMPLANT | MAX | Substantially Equivalent | |
| K082187 | BIOMET ANTERIOR LUMBAR PLATE | KWQ | Substantially Equivalent | |
| K063346 | PRO OSTEON 500R | MQV | Substantially Equivalent | |
| K062494 | EBI OPTILOCK UPPER EXTREMITY PLATING SYSTEM | HRS | Substantially Equivalent | |
| K062810 | SOLITAIRE ANTERIOR SPINAL SYSTEM | MQP | Substantially Equivalent | |
| K062685 | EBI ARAY SPINAL SYSTEM | NKB | Substantially Equivalent | |
| K061978 | EBI, L.P.'S LINE EXTENSION TO THE ARRAY SPINAL SYSTEM | MNI | Substantially Equivalent | |
| K061441 | EBI 5.5 HELICAL FLANGE SPINAL SYSTEM | MNH | Substantially Equivalent | |
| K061563 | EBI ARRAY SPINAL SYSTEM | NKB | Substantially Equivalent | |
| K061016 | EBI ESL PEEK-OPTIMA SPINE SYSTEM | MQP | Substantially Equivalent | |
| K061098 | EBI OPTILOCK PERIARTICULAR PLATING SYSTEM | HRS | Substantially Equivalent | |
| K060148 | EBI VERTEBROPLASTY SYSTEMS | NDN | Substantially Equivalent | |
| K060379 | EBI ANTERIOR CERVICAL PLATE SYSTEM | KWQ | Substantially Equivalent | |
| K052239 | EBI DYNAFIX VISION FOOTPLATE SYSTEM | KTT | Substantially Equivalent | |
| K051724 | ACUMEN IMAGE GUIDED SURGICAL SYSTEM | HAW | Substantially Equivalent | |
| K050118 | EBI TROCHANTERIC NAIL SYSTEM | HSB | Substantially Equivalent | |
| K042772 | EBI ARRAY SPINAL FIXATION SYSTEM AND SPINELINK II SPINAL FIXATION DEVICE | NKB | Substantially Equivalent | |
| K042268 | EBI CAS SPINE SPACER SYSTEM | MQP | Substantially Equivalent | |
| K042237 | EBI PERIARTICULAR PLATING SYSTEM | HRS | Substantially Equivalent | |
| K033918 | EBI LACTOSORB GRAFT CONTAINMENT SYSTEM | HRS | Substantially Equivalent | |
| K040935 | EBI XFIX DFS SYSTEM | KTT | Substantially Equivalent | |
| K040908 | EBI DISTAL RADIUS PLATING SYSTEM | HRS | Substantially Equivalent | |
| K040833 | MODIFICATION TO EBI XFIX VISION FIXATION SYSTEM | KTT | Substantially Equivalent | |
| K040482 | EBI ESL SPINE SPACER SYSTEM | MQP | Substantially Equivalent | |
| K033312 | EBI TOP LOADING MAS SPINAL FIXATION SYSTEM | NKB | Substantially Equivalent | |
| K033635 | MODIFICATION TO EBI XFIX VISION FIXATION SYSTEM | KTT | Substantially Equivalent | |
| K031732 | EBI ACUMEN SURGICAL NAVIGATION SYSTEM | HAW | Substantially Equivalent | |
| K031919 | EBI XFIX DFS SYSTEM | KTT | Substantially Equivalent | |
| K032390 | MODIFICATION TO EBI TARGETCATH FLUORO-GUIDED STEERABLE CATHETER SYSTEM | BSO | Substantially Equivalent | |
| K031354 | EBI OMEGA21 SPINAL FIXATION SYSTEM | MNI | Substantially Equivalent | |
| K031424 | EBI SPINELINK SPINAL FIXATION SYSTEM | NKB | Substantially Equivalent | |
| K031355 | EBI SPINELINK - II SPINAL FIXATION SYSTEM | NKB | Substantially Equivalent | |
| K031093 | EBI XFIX OPTIROM KNEE FIXATOR | KTT | Substantially Equivalent | |
| K031423 | EBI P148 SPINAL FIXATION SYSTEM | MNH | Substantially Equivalent | |
| K031645 | EBI XFIX DFS SYSTEM | KTT | Substantially Equivalent | |
| K030706 | EBI DYNAFIX COMPRESSION BONE SCREW | HWC | Substantially Equivalent | |
| K030372 | MODIFICATION TO EBI DYNAFIX DIAPHYSEAL CORRECTION SYSTEM | KTT | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2242816 | 2242816 | EBI, LLC | 1 Gatehall Rd., PARSIPPANY, NJ 07054 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
- LXTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite
- KWPAppliance, Fixation, Spinal Interlaminal
- KWQAppliance, Fixation, Spinal Intervertebral Body
- HRXArthroscope
- BSOCatheter, Conduction, Anesthetic
- NDNCement, Bone, Vertebroplasty
- MQVFiller, Bone Void, Calcium Compound
- MAXIntervertebral Fusion Device With Bone Graft, Lumbar
- OVEIntervertebral Fusion Device With Integrated Fixation, Cervical
- HAWNeurological Stereotaxic Instrument
- MNIOrthosis, Spinal Pedicle Fixation
- MNHOrthosis, Spondylolisthesis Spinal Fixation
- HRSPlate, Fixation, Bone
- NDFPlate, Fixation, Bone, Non-Spinal, Metallic
- HSBRod, Fixation, Intramedullary And Accessories
- HWCScrew, Fixation, Bone
- MQPSpinal Vertebral Body Replacement Device
- LOFStimulator, Bone Growth, Non-Invasive
- LWBStimulator, Functional Neuromuscular, Scoliosis
- LOEStimulator, Invasive Bone Growth
- NKBThoracolumbosacral Pedicle Screw System
Recall records
Showing 25 of 61| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1619-2024 | 48" Lead Wires, Replacement Part Number: 1067724-4 | Damage to the lead wire sheath (black cable) component and causing exposure of the wires, potentially lead to no therapeutic treatment signal being delivered to the electrodes, and result in delay of treatment | Class II | Open, Classified | |
| Z-1618-2024 | 20" Lead Wires, Replacement Part Number: 1067724-2 | Damage to the lead wire sheath (black cable) component and causing exposure of the wires, potentially lead to no therapeutic treatment signal being delivered to the electrodes, and result in delay of treatment | Class II | Open, Classified | |
| Z-1617-2024 | Biomet OrthoPak Non-invasive Bone Growth Stimulator System-Indicated for the treatment of an established nonunion acquired secondary to trauma, excluding vertebrae and all flat bones. Part Number: 1067718 | Damage to the lead wire sheath (black cable) component and causing exposure of the wires, potentially lead to no therapeutic treatment signal being delivered to the electrodes, and result in delay of treatment | Class II | Open, Classified | |
| Z-1616-2024 | Biomet SpinalPak Non-invasive Spine Fusion Stimulator System- Indicated for the treatment of an established nonunion acquired secondary to trauma, excluding vertebrae and all flat bones, Part Number: 1067716 | Damage to the lead wire sheath (black cable) component and causing exposure of the wires, potentially lead to no therapeutic treatment signal being delivered to the electrodes, and result in delay of treatment | Class II | Open, Classified | |
| Z-0874-2015 | Solitaire-C Cervical Spacer System a) 14-531593 Drill/Awl Sleeve b) 14-531594 Spring-Loaded Drill/Awl Sleeve Intended to stabilize cervical spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft with or without supplemental fixation. | A design deficiency was discovered whereby the Drill/Awl Sleeve and Spring-Loaded Drill/Awl Sleeve instruments (the Sleeves) allow the mating Drill and Awl instruments to penetrate 1.0 mm beyond their intended depths during screw hole preparation. | Class II | Terminated | |
| Z-0909-2015 | Cypher MIS Screw System-The system includes screws, various types and sizes of rods, and set screws. Various instruments are also available for use by the surgeon to facilitate implantation of the device. Non-cervical spinal fixation device intended for immobilization and stabilization as an adjunct to fusion. | Inoperative screw head seat splay and/or fracture as a result of positioning of the rod which is a part of the Cypher MIS Screw System. | Class II | Terminated | |
| Z-1811-2014 | Biomet Spine, Cypher MIS Screw Inserter, Catalog number 14-501669, instrument for Spinal Screw Fixation System. | The Cypher MIS Screw Inserter may exhibit an increased rate of instrument tip failure. | Class II | Terminated | |
| Z-0411-2014 | Shortened Plug Driver; Low Volume Specialty Device; Qty:1; Rx Only; Non Sterile; Biomet Spine, Parsippany, NJ 07054 The Polaris Spinal Systems is a non-cervical spinal fixation device intended for immobilization and stabilization as an adjunct to fusion as a pedical screw fixation system, a posterior hook and sacral/iliac screw fixation system, or as an anterior or anterolateral fixation system. Pedicle screw fixation is limited to skeletal mature patients for use with autograft and/or allograft. The device is indicated for all the following indications:degenerative disc disease (defined as discogeneic back pain with degeneration of the disk confirmed by history and radiographic studies), spondylolisthesis, and or lordosis) tumor, stenosis, pseudoarthrosis, or failed previous fusion | Biomet received a complaint on 5/20/2013 reporting that the tip of the instrument sheared off during a removal case. | Class II | Terminated | |
| Z-0359-2014 | BIOMET Spine, 5.5 TI 5.5x50mm Translation Screw Polaris 5.5 TI Spinal System. Rx Only. Non-Sterile. Intended for immobilization and stabilization as an adjunct to fusion as a pedicle screw fixation system | Polaris Translation Screw Failures were recently reported to Biomet Spine. These failures are generally described as dissociation of the screw head from the shaft of the Polaris Translation Screw. | Class II | Terminated | |
| Z-2214-2013 | Cypher MIS Screw System, Biomet Spine Parsippany, NJ 07054. The Cypher MIS Screw System is a non-cervical spinal fixation device. 1)Screw Tower - REF 14-501660 2) Rod Reduce - REF 14-501661 3) Counter Torque - REF 14-501662 | Several complaints were reported to exhibit screw head splay in the Cypher MIS Screw System. | Class II | Terminated | |
| Z-2292-2013 | Solitaire-35 Peek Solitaire Anterior Spinal System. The Solitaire-35 is an intervertebral body fusion device. | Several complaints were recorded regarding one of the three screws driving through the cage of the Solitaire 35 implant. | Class II | Terminated | |
| Z-0954-2013 | Biomet Spine Polaris 5.5 Button Lock Screw Inserter. Catalog Number 14-500178. The Polaris Spinal System is a non-cervical, pedicle screw spinal fixation device. | Increased risk of failure at the driver tip during screw insertion or removal. | Class II | Terminated | |
| Z-0536-2013 | Biomet Polaris 5.5 Button Lock Screw Inserter. Catalog number 14-500178 | Broken screw insertor hardness was measured and found to be below the acceptable limits. | Class II | Terminated | |
| Z-0131-2011 | ARRAY and POLARIS Spinal System Medium Cross Connector Non Sterile Biomet Spine, Parsippany, NJ. 07054 | One of the two connector ends of the medium cross connector may not be fully secured to the rod after tightening. This may not be readily apparent to the operating surgeon, resulting in inadequate torsional stability. | Terminated | ||
| Z-2312-2009 | Multi-Axial Screw (TI); 8.00MM (D) x 70MM(L) W/Collar; Biomet Spine, Parsippany, NJ 07054 The screw devices are an internal fixation device intended to aid in the alignment and stabilization of fractures to the skeletal system until healing has occurred. Implants used in this application include non sterile and sterile bone screws. | Some devices could have been made with raw material lots that may have inclusions, and could result in decreased strength of the device. | Terminated | ||
| Z-2311-2009 | Bone Screw 7MM (D) x 35 MM (L) Telescopic Plate Spacer Thoracolumbar Spinal System; Made in USA Biomet Spine, Parsippany, NJ 07054 The screw devices are an internal fixation device intended to aid in the alignment and stabilization of fractures to the skeletal system until healing has occurred. Implants used in this application include non sterile and sterile bone screws. | Some devices could have been made with raw material lots that may have inclusions, and could result in decreased strength of the device. | Terminated | ||
| Z-2310-2009 | Bone Screw 6MM (D) x 35MM (L) Telescopic Plate Spacer, Thoracolumbar Spinal System Made in USA, Biomet Spine, Parsippany, NJ 07054 The screw devices are an internal fixation device intended to aid in the alignment and stabilization of fractures to the skeletal system until healing has occurred. Implants used in this application include non sterile and sterile bone screws. | Some devices could have been made with raw material lots that may have inclusions, and could result in decreased strength of the device. | Terminated | ||
| Z-2309-2009 | Fixed Closed Screw (Ti); 6.0MM (D) x 40 MM (L) Made In USA, Biomet Spine, Parsippany, NJ 07054 The screw devices are an internal fixation device intended to aid in the alignment and stabilization of fractures to the skeletal system until healing has occurred. implants used in this application include non sterile and sterile bone screws. | Some devices could have been made with raw material lots that may have inclusions, and could result in decreased strength of the device. | Terminated | ||
| Z-2308-2009 | Fixed Closed Screw (Ti); 5.0MM (D) x 25MM (L); Made in USA, Biomet Spine, Parsippany, NJ 07054 The screw devices are an internal fixation device intended to aid in the alignment and stabilization of fractures to the skeletal system until healing has occurred. Implants used in this application include non sterile and sterile bone screws. | Some devices could have been made with raw material lots that may have inclusions, and could result in decreased strength of the device. | Terminated | ||
| Z-2307-2009 | Fixed Open Screw (TI); 7.0MM (D) x 30MM (L); Made In USA, Biomet Spine, Parsippany, NJ 07054 The screw devices are an internal fixation device intended to aid in the alignment and stabilization of fractures to the skeletal system until healing has occurred. Implants used in this application include non sterile and sterile bone screws. | Some devices could have been made with raw material lots that may have inclusions, and could result in decreased strength of the device. | Terminated | ||
| Z-2306-2009 | Fixed Closed Screw, 6.5mm (D) x 40mm (L), Made in USA; Biomet Spine, Parsippany, NJ The screw devices are an internal fixation device intended to aid in the alignment and stabilization of fractures to the skeletal system until healing has occurred. Implants used in this application include non sterile and sterile bone screws. | Some devices could have been made with raw material lots that may have inclusions, and could result in decreased strength of the device. | Terminated | ||
| Z-2305-2009 | Pediatric Femoral Nail 5.5MM (d) x 36 CM (L) Rx only, Sterile; Biomet, 100 Interpace Parkway, Parsippany, NJ 07054 The screw devices are an internal fixation device intended to aid in the alignment and stabilization of fractures to the skeletal system until healing has occurred. Implants used in this application include non sterile and sterile bone screws. | Some devices could have been made with raw material lots that may have inclusions, and could result in decreased strength of the device. | Terminated | ||
| Z-2304-2009 | Pediatric Femoral Nail 5.5MM (d) x 32 CM (L) Rx only, Sterile; Biomet, 100 Interpace Parkway, Parsippany, NJ 07054The screw devices are an internal fixation device intended to aid in the alignment and stabilization of fractures to the skeletal system until healing has occurred. Implants used in this application include non sterile and sterile bone screws. | Some devices could have been made with raw material lots that may have inclusions, and could result in decreased strength of the device. | Terminated | ||
| Z-2303-2009 | Pediatric Femoral Nail 5.5MM (d) x 30 CM (L) Rx only, Sterile; Biomet, 100 Interpace Parkway, Parsippany, NJ 07054 The screw devices are an internal fixation device intended to aid in the alignment and stabilization of fractures to the skeletal system until healing has occurred. Implants used in this application include non sterile and sterile bone screws. | Some devices could have been made with raw material lots that may have inclusions, and could result in decreased strength of the device. | Terminated | ||
| Z-2302-2009 | Pediatric Femoral Nail 5.5MM (d) x 28 CM (L) Rx only, Sterile; Biomet, 100 Interpace Parkway, Parsippany, NJ 07054 The screw devices are an internal fixation device intended to aid in the alignment and stabilization of fractures to the skeletal system until healing has occurred. Implants used in this application include non sterile and sterile bone screws. | Some devices could have been made with raw material lots that may have inclusions, and could result in decreased strength of the device. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain