Spinal Concepts, Inc.
Austin, TX, US
Spinal Concepts, Inc. appears in FDA device records in Austin, TX. FDA records list 46 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show 24 recalls for this company.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Spinal Concepts, Inc. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Abbott Spine, Inc.510(k), recall
510(k) clearance history
FDA records hold 46 510(k) clearances for Spinal Concepts, Inc. between 1997 and 2009. The busiest year on record is 2002, with 9. The most recent is 2009, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1997 | 3 |
| 1998 | 3 |
| 1999 | 1 |
| 2000 | 1 |
| 2001 | 2 |
| 2002 | 9 |
| 2003 | 9 |
| 2004 | 3 |
| 2005 | 5 |
| 2006 | 4 |
| 2007 | 2 |
| 2008 | 3 |
| 2009 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K090060 | NEXLINK OCT SYSTEM, MODEL 7000 SERIES | KWP | Substantially Equivalent | |
| K082032 | SEQUOIA SPINAL SYSTEM (MODEL 3306), SPEEDLINK TRANSVERSE CONNECTOR (MODELS 3308, 3309, 3310) | NKB | Substantially Equivalent | |
| K081622 | UNIVERSAL CLAMP STAINLESS STEEL SYSTEM | JDQ | Substantially Equivalent | |
| K073202 | ARDIS SPACER | MAX | Substantially Equivalent | |
| K072672 | SEQUOIA SPINAL SYSTEM, MODEL 3300 SERIES | NKB | Substantially Equivalent | |
| K071174 | PATHFINDER SYSTEM POLYAXIAL PEDICLE SCREWS | NKB | Substantially Equivalent | |
| K062505 | NEX-LINK SPINAL FIXATION SYSTEM OFFSET CONNECTORS, 2121-XX SERIES | MNI | Substantially Equivalent | |
| K060634 | NEX-LINK SPINAL FIXATION SYSTEM ROD TO ROD CONNECTORS, MODELS 725, 726 SERIES | MNI | Substantially Equivalent | |
| K060009 | ABBOTT SPINE UNIVERSAL CLAMP SYSTEM | JDQ | Substantially Equivalent | |
| K052566 | NEX-LINK SPINAL FIXATION SYSTEM OPEN POLYAXIAL SCREWS, MODELS 2112, 2113, 2118, 2119, 2120. NEX-LINK SPINAL FIXATION SY | MNI | Substantially Equivalent | |
| K052638 | ABBOTT SPINE, INC. SPINNAKER SYSTEM | KNW | Substantially Equivalent | |
| K052247 | NEX-LINK SPINAL FIXATION SYSTEM VARIABLE CROSSLINK, MODEL 721-XX | KWP | Substantially Equivalent | |
| K052072 | THE SC-ACUFIX ANT-CER DYNAMIC CERVICAL PLATE SYSTEM SINGLE LEVEL PLATES | KWQ | Substantially Equivalent | |
| K051000 | FORTITUDE VUE VERTEBRAL BODY REPLACEMENT DEVICE | MQP | Substantially Equivalent | |
| K050706 | HARMONY PORT SYSTEM, MODEL 1907 SERIES | GZT | Substantially Equivalent | |
| K040096 | SPINAL CONCEPTS, INC. TANDEM SPINOUS PROCESS PLATE SYSTEM | KWP | Substantially Equivalent | |
| K033663 | SPINAL CONCEPTS INC. CODA | MQP | Substantially Equivalent | |
| K033517 | SPINAL CONCEPTS INC. CADENCE AND TRAXIS | MQP | Substantially Equivalent | |
| K031855 | SPINAL CONCEPTS, INC. INSIGHT PEDICLE SCREW SYSTEM | KWQ | Substantially Equivalent | |
| K031985 | SPINAL CONCEPTS INC. NEX-LINK SPINAL FIXATION SYSTEM | MNI | Substantially Equivalent | |
| K031318 | TRAXIS CEMENT RESTRICTOR | JDK | Unknown | |
| K031672 | SPINAL CONCEPTS, INC. INFIX SYSTEM | MQP | Substantially Equivalent | |
| K031837 | MODIFICATION TO FORTITUDE CEMENT RESTRICTOR | JDK | Substantially Equivalent | |
| K030087 | SPINAL CONCEPTS, INC. BACFIX TI SPINAL SYSTEM | NKB | Substantially Equivalent | |
| K031914 | SPINAL CONCEPTS, INC. CADENCE AND FORTITUDE | MQP | Substantially Equivalent | |
| K030625 | SPINAL CONCEPTS INC. PATHFINDER | NKB | Substantially Equivalent | |
| K024326 | SPINAL CONCEPTS, INC. ANT-CER DYNAMIC ANTERIOR CERVICAL PLATE SYSTEM | KWQ | Substantially Equivalent | |
| K023647 | CADENCE PEEK CEMEENT RESTRICTOR | JDK | Substantially Equivalent | |
| K023644 | MODIFICATION TO INCOMPASS SPINAL FIXATION SYSTEM | MNI | Substantially Equivalent | |
| K021564 | INCOMPASS SPINAL FIXATION SYSTEM | KWQ | Substantially Equivalent | |
| K021719 | FORTITUDE CEMENT RESTRICTOR | JDK | Unknown | |
| K022218 | CADENCE CEMENT RESTRICTOR | JDK | Substantially Equivalent | |
| K021009 | OCTAFIX OCCIPITAL CERVICAL PLATING SYSTEM | KWP | Substantially Equivalent | |
| K020611 | UNIVERSAL BONE PLATE III SYSTEM (UBP III) | HRS | Substantially Equivalent | |
| K013979 | SC-ACUFIX THINLINE ANTERIOR CERVICAL PLATE SYSTEM | KWQ | Substantially Equivalent | |
| K013887 | BACFIX SPINAL FIXATION SYSTEM | MNH | Substantially Equivalent | |
| K010563 | END-TO-END AND SIDE-BY-SIDE CONNECTORS | MNI | Substantially Equivalent | |
| K003351 | PARSFIX CABLE-SCREW SYSTEM | KWP | Substantially Equivalent | |
| K002082 | SPEEDLINK TRANSVERSE CONNECTOR | KWP | Substantially Equivalent | |
| K990005 | SPINAL CONCEPTS, INC. (SCI) ANTERIOR CERVICAL PLATE SYSTEM | KWQ | Substantially Equivalent | |
| K983260 | MODIFICATION TO SPINAL CONCEPTS BACFIX TI SPINAL FIXATION SYSTEM | MNI | Substantially Equivalent | |
| K983258 | MODIFICATION TO SPINAL CONCEPTS BACFIX SPINAL FIXATION SYSTEM | MNI | Substantially Equivalent | |
| K973687 | SPINAL CONCEPTS, INC., BACFIX TI SPINAL FIXATION SYSTEM | MNH | Substantially Equivalent for Some Indications | |
| K974020 | SPINAL CONCEPTS, INC., CFIX CABLE SYSTEM | JDQ | Substantially Equivalent | |
| K973586 | SPINAL CONCEPTS, INC., UNIVERSAL BONE PLATE SYSTEM II | HWC | Substantially Equivalent for Some Indications | |
| K964404 | BACFIX SPINAL FIXATION SYSTEM | KWP | Substantially Equivalent for Some Indications |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- KWPAppliance, Fixation, Spinal Interlaminal
- KWQAppliance, Fixation, Spinal Intervertebral Body
- JDQCerclage, Fixation
- KNWInstrument, Biopsy
- MAXIntervertebral Fusion Device With Bone Graft, Lumbar
- MNIOrthosis, Spinal Pedicle Fixation
- MNHOrthosis, Spondylolisthesis Spinal Fixation
- HRSPlate, Fixation, Bone
- JDKProsthesis, Hip, Cement Restrictor
- GZTRetractor, Self-Retaining, For Neurosurgery
- HWCScrew, Fixation, Bone
- MQPSpinal Vertebral Body Replacement Device
- NKBThoracolumbosacral Pedicle Screw System
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1784-2008 | PathFinder Cannulated T-Handle Bone Awl, Part Number 1155-2; distributed by Abbott Spine, Inc., Austin, TX 78727. | Breakage - Tips on the Pathfinder Bone Awl may bend or break prematurely. The firm has received internal non-conformances and complaints where the tips of the Awl were worn and damaged. Of the tip breaks, six have had material missing. During the same period, there were 15 complaints reported where the tip broke off at the weld after repeated use (1-3 years). The firm found several possible ca | Terminated | ||
| Z-1593-2008 | PathFinder Spinal Fixation System T-Handle Driver; Part 2151-7 (13" shaft); Non-sterile, Reusable Instrument; manufactured by Abbott Spine, Austin, TX 78727. | Reports received regarding disassembly of T-Handle Driver components during surgery dropping the closure top into the surgical site. | Terminated | ||
| Z-1592-2008 | InCompass Spinal Fixation System T-Handle Driver; Part #2151-4 (9.5" shaft) and 2151-5 (13" shaft); Non-sterile, Reusable Instrument; manufactured by Abbott Spine, Austin, TX 78727. | Reports received regarding disassembly of T-Handle Driver components during surgery dropping the closure top into the surgical site. | Terminated | ||
| Z-1479-2008 | Sequoia Spinal System Surgical Kits; Pedicle screw spinal system; Non-sterile (kits intended to be sterilized prior to use); Rx Only; The Sequoia Spinal System is designed to aid in the surgical correction of several types of spinal conditions. The product is a system of smaller devices used to provide stabilization during the development of a solid fusion mass. | Screw Head Dissociation: The polyaxial screw head may dissociate from screw shaft during surgery. Also, the polyaxial screw driver is experiencing difficulty (broken/bent driver shafts, difficulty attaching screws to the driver and jamming of the collet.) | Terminated | ||
| Z-0880-2008 | Comfort T-Handle Hudson Connector with Impactor Cap; Part #1006-1; handle is component of the following consignment surgical kits: Harmony 2700-0001-PL, Harmony 2700-0009-PL, Harmony 2900-0001-PL, Harmony 2900-0002-PL, Cadence 1500-0002-PL and Cadence 1500-0008-PL; Distributed by Abbott Spine, Austin, TX 78727. | Dislodged Collar Spring; The collar spring binding on the shaft of generic handle used with multiple surgical instruments has the potential to release the device's internal bearings during use. | Terminated | ||
| Z-0005-2008 | PathFinder Bone Drill-Awl-Tap, a part of the PathFinder spinal stabilization system, Part Number 1156-60. | Tip of PathFinder surgical instrument broke during procedure. | Terminated | ||
| Z-0004-2008 | PathFinder Bone Drill-Awl-Tap, a part of the PathFinder spinal stablization system, Part Number 1156-50. | Tip of PathFinder surgical instrument broke during procedure. | Terminated | ||
| Z-0355-2007 | TraXis Fixed Rasp in sizes: 7mm, 9mm, 11mm, 13mm and 15mm; for use with TraXis vertebral body replacement system | Tip of devices may dislodge while in use during surgery. | Terminated | ||
| Z-0354-2007 | TraXis Fixed Trial in sizes: 7mm, 9mm, 11mm, 13mm and 15mm; part of TraXis vertebral body replacement system | Tip of devices may dislodge while in use during surgery. | Terminated | ||
| Z-1154-06 | Stericover/ Sterile Disposible Polyethylene Drape ---Universal Video Camera/ Laser Arm Equipment Cover; 7'' x 96''. | Non-sterility-Distributor testing of outside manufacturer's product (Sterimed, Inc) revealed positive sterility test results. | Terminated | ||
| Z-0296-06 | SC-AcuFix Core Instruments Surgical Techniques covering SC-AcuFix Ant-Cer Anterior Cervical Plating Systems. | Modification to labeling for surgical implant. | Terminated | ||
| Z-0295-06 | SC-AcuFix Core Instruments Surgical Techniques covering SC-AcuFix ThinLine Anterior Cervical Plating Systems. | Modification to labeling for surgical implant. | Terminated | ||
| Z-0294-06 | SC-AcuFix Core Instruments Surgical Techniques covering SC-AcuFix Corpectomy Anterior Cervical Plating Systems. | Modification to labeling for surgical implant. | Terminated | ||
| Z-0293-06 | SC-AcuFix Core Instruments Surgical Techniques covering SC-AcuFix SlimLine and SlimLine Hybrid Anterior Cervical Plating Systems. | Modification to labeling for surgical implant. | Terminated | ||
| Z-0292-06 | SC-AcuFix Core Instruments Surgical Techniques covering SC-AcuFix SlimLine, SlimLine Hybrid, Corpectomy, ThinLine and Ant-Cer Anterior Cervical Plating Systems. | Modification to labeling for surgical implant. | Terminated | ||
| Z-0502-06 | TraXis Vue Spinal Implant System, Part #2601-090921 | Implants were manufactured without radiographic markers. | Terminated | ||
| Z-1343-04 | Harmony MIS Life Instruments, Lumbar Spacer Systems manufactured by Spinal Concepts, Austin, Texas. Part numbers 2851-1-01, 2851-1-30, 2851-2-01, 2851-2-30, 2851-3-01, 2851-3-30, 2851-4-01, 2851-4-30, 2851-4-31, 2851-5-01, 2851-5-30, 2852-2, 2852-4, 2854-1, 2857-1, 2857-2, 2862-1, 2858-1, 2859-1, and 2861-5 | Handle becomes loose after repeated use. | Terminated | ||
| Z-1038-04 | Ant-Cer Dynamic Cervical Plating System Literature. Device is manufactured by Spinal Concepts, Austin, TX | Recall of product literature that describes use of the device. | Terminated | ||
| Z-0808-04 | 1757-1: Compressor/Distractor Instrument (aka Plate Distractor Forceps), and product literature. Devices are manufactured by Spinal Concepts, Inc., An Abbott Laboratories Company | Design has insufficient articulating distance between the two component plates to prevent disassociation in vivo. | Terminated | ||
| Z-0807-04 | One-level Ant-Cer Plates (Assembly Level). 1706-1024, 1706-1026, 1706-1028, 1706-1030, 1706-1032, and product literature. Devices are manufactured by Spinal Concepts, Inc., An Abbott Laboratories Company | Design has insufficient articulating distance between the two component plates to prevent disassociation in vivo. | Terminated | ||
| Z-0880-05 | SC-AcuFix Thinline Low-Profile Anterior Cervical Plate System manufactured by Spinal Concepts, Inc., An Abbott Laboratories Company, Austin, Texas | Complaints were recieved where swivels came out of plate and where the screw went through the plate. | Terminated | ||
| Z-0922-04 | 955-5 BackFix Coldwelder II with straight tip manufactured by Spinal Concepts, Austin, Texas | The instrument can break during surgery causing delay of surgery and/or fragments in the surgical site. | Terminated | ||
| Z-0921-04 | 955-4 BacFix Coldwelder II with angled tip, manufactured by Spinal Concepts, Austin, Texas | The instrument can break during surgery causing delay of surgery and/or fragments in the surgical site. | Terminated | ||
| Z-0920-04 | 955-3 BacFix Coldwelder, manufactured by Spinal Concepts, Austin, Texas | The instrument can break during surgery causing delay of surgery and/or fragments in the surgical site. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain