Seaspine, Inc.
San Diego, CA, US
Seaspine, Inc. appears in FDA device records in San Diego, CA. FDA records list 33 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show 11 recalls for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 33 510(k) clearances for Seaspine, Inc. between 2003 and 2023. The busiest year on record is 2008, with 4. The most recent is 2023, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2003 | 3 |
| 2004 | 2 |
| 2005 | 3 |
| 2006 | 2 |
| 2007 | 2 |
| 2008 | 4 |
| 2009 | 3 |
| 2010 | 1 |
| 2011 | 3 |
| 2012 | 2 |
| 2013 | 3 |
| 2014 | 2 |
| 2015 | 1 |
| 2021 | 1 |
| 2023 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K231654 | NorthStar OCT System | NKG | Substantially Equivalent | |
| K212135 | Dry DBM- A Putty | MQV | Substantially Equivalent | |
| K150469 | Integra Laminoplasty System | NQW | Substantially Equivalent | |
| K142488 | SeaSpine Spacer System - (Hollywood, Pacifica, Redondo, Ventura) NanoMetalene, Cambria NanoMetalene , Vu aPOD-L NanoMetalene, Vu ePOD NanoMetalene | MAX | Substantially Equivalent | |
| K133418 | INTEGRA EXPANDABLE INTERVEREBRAL BODY FUSION DEVICE (IBD) SYSTEM | MAX | Substantially Equivalent | |
| K132859 | INTEGRA FACET FIXATION SYSTEM | MRW | Substantially Equivalent | |
| K121924 | INTEGRA INTERSPINOUS PROCESS SYSTEM | PEK | Substantially Equivalent | |
| K130830 | INTEGRA LAMINOPLASTY SYSTEM | NQW | Substantially Equivalent | |
| K122571 | MALIBU SPINAL SYSTEM WITH THE DAYTONA DEFORMITY SYSTEM | NKB | Substantially Equivalent | |
| K112206 | CARDIFF ANTERIOR CERVICAL PLATE SYSTEM | KWQ | Substantially Equivalent | |
| K111671 | SEASPINE MONOPOLAR PROBE SYSYEM | ETN | Substantially Equivalent | |
| K102026 | SEASPINE SPACER SYSTEM | MAX | Substantially Equivalent | |
| K103297 | REDONDO-L | MAX | Substantially Equivalent | |
| K092521 | ZUMA-C | OVE | Substantially Equivalent | |
| K082309 | CAMBRIA | ODP | Substantially Equivalent | |
| K083338 | CARDIFF ANTERIOR CERVICAL PLATE SYSTEM | KWQ | Substantially Equivalent | |
| K083089 | NEWPORT SPINAL SYSTEM | NKB | Substantially Equivalent | |
| K082926 | ZUMA, MODEL 55-XXXX/56-XXXX | OVD | Substantially Equivalent | |
| K082310 | HOLLYWOOD, PACIFICA, REDONDO, VENTURA | MAX | Substantially Equivalent | |
| K072729 | SIERRA | KWP | Substantially Equivalent | |
| K080526 | SIERRA SYSTEM | KWP | Substantially Equivalent | |
| K072605 | MALIBU SPINAL SYSTEM | NKB | Substantially Equivalent | |
| K071726 | ZUMA | MQP | Substantially Equivalent | |
| K062934 | SIERRA | MNI | Substantially Equivalent | |
| K061342 | MALIBU SPINAL SYSTEM | NKB | Substantially Equivalent | |
| K052170 | SEASPINE VBR SYSTEM | MQP | Substantially Equivalent | |
| K051942 | MALIBU SPINAL SYSTEM | KWP | Substantially Equivalent | |
| K051663 | MALIBU SPINAL SYSTEM | NKB | Substantially Equivalent | |
| K043232 | UCR SPINAL SYSTEM | NKB | Substantially Equivalent | |
| K040130 | ANTERIOR LUMBAR BUTTRESS SYSTEM | KWQ | Substantially Equivalent | |
| K032739 | UCR SPINAL SYSTEM | MNI | Substantially Equivalent | |
| K032368 | SONOMA ANTERIOR CERVICAL PLATE SYSTEM | KWQ | Substantially Equivalent | |
| K031381 | UCR SPINAL SYSTEM, LAMINAR HOOKS, PEDICLE HOOKS, AND INSTRUMENTS | MNI | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- KWPAppliance, Fixation, Spinal Interlaminal
- KWQAppliance, Fixation, Spinal Intervertebral Body
- MQVFiller, Bone Void, Calcium Compound
- ODPIntervertebral Fusion Device With Bone Graft, Cervical
- MAXIntervertebral Fusion Device With Bone Graft, Lumbar
- OVEIntervertebral Fusion Device With Integrated Fixation, Cervical
- OVDIntervertebral Fusion Device With Integrated Fixation, Lumbar
- MNIOrthosis, Spinal Pedicle Fixation
- NQWOrthosis, Spine, Plate, Laminoplasty, Metal
- NKGPosterior Cervical Screw System
- MQPSpinal Vertebral Body Replacement Device
- PEKSpinous Process Plate
- ETNStimulator, Nerve
- MRWSystem, Facet Screw Spinal Device
- NKBThoracolumbosacral Pedicle Screw System
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1841-2014 | Integra UCR 3mm Hex, Large Axial Driver. The UCR Hex Axial Driver is a surgical instrument used to implant and remove polyaxial screws of varying reduction heights provided with the Malibu", UCR, and NewPort" Systems. The Malibu", UCR, NewPort" Systems are intended to be used as a temporary or permanent posterior, non-cervical implant to correct spinal disorders and provide stabilization of the spine to permit the biological process of spinal fusions to occur. Accepted standard techniques of spinal fusion are an integral part of the implantation of these systems. Indications For Use: The Malibu", UCR, NewPort" Systems are intended to be used as a temporary or permanent posterior, non-cervical implant to correct spinal disorders and provide stabilization of the spine to permit the biological process of spinal fusions to occur. Accepted standard techniques of spinal fusion are an integral part of the implantation of these systems. The intended use of the Malibu, UCR, and NewPort Systems, when used as a Pedicle Screw Spinal System or Spondylolisthesis Spinal Fixation Device System, is to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine. | Integra has identified through an investigation of complaints that there may be the potential for the tip of a single lot number of the UCR 3mm Hex, Large Axial Driver, 91-1123 to twist or become rounded during use. | Class II | Terminated | |
| Z-1927-2009 | Malibu Polyaxial Reduction Screw, 6.5 x 50mm Part Number 13-6550 Malibu Spinal System when used as a Pedicle Screw Spinal System or Spondylolisthesis Spinal Fixation Device System is to provide immobilization in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine. | SeaSpine has received reports relating to rust on the internal washer contained within the titanium seat assembly of certain Malibu Polyaxial and Malibu Reduction Screws. | Terminated | ||
| Z-1926-2009 | Malibu Polyaxial Reduction Screw, 6.5 x 45mm Part Number 13-6545 Malibu Spinal System when used as a Pedicle Screw Spinal System or Spondylolisthesis Spinal Fixation Device System is to provide immobilization in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine. | SeaSpine has received reports relating to rust on the internal washer contained within the titanium seat assembly of certain Malibu Polyaxial and Malibu Reduction Screws. | Terminated | ||
| Z-1925-2009 | Malibu Polyaxial Reduction Screw, 6.5 x 40mm Part Number 13-6540 Malibu Spinal System when used as a Pedicle Screw Spinal System or Spondylolisthesis Spinal Fixation Device System is to provide immobilization in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine. | SeaSpine has received reports relating to rust on the internal washer contained within the titanium seat assembly of certain Malibu Polyaxial and Malibu Reduction Screws. | Terminated | ||
| Z-1924-2009 | Malibu Polyaxial Screw, 7.5 x 70mm Part Number 12-7570 Malibu Spinal System when used as a Pedicle Screw Spinal System or Spondylolisthesis Spinal Fixation Device System is to provide immobilization in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine. | SeaSpine has received reports relating to rust on the internal washer contained within the titanium seat assembly of certain Malibu Polyaxial and Malibu Reduction Screws. | Terminated | ||
| Z-1923-2009 | Malibu Polyaxial Screw, 7.5 x 35mm Part Number 12-7535 Malibu Spinal System when used as a Pedicle Screw Spinal System or Spondylolisthesis Spinal Fixation Device System is to provide immobilization in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine. | SeaSpine has received reports relating to rust on the internal washer contained within the titanium seat assembly of certain Malibu Polyaxial and Malibu Reduction Screws. | Terminated | ||
| Z-1922-2009 | Malibu Polyaxial Screw, 6.5 x 50mm Part Number 12-6550 Malibu Spinal System when used as a Pedicle Screw Spinal System or Spondylolisthesis Spinal Fixation Device System is to provide immobilization in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine. | SeaSpine has received reports relating to rust on the internal washer contained within the titanium seat assembly of certain Malibu Polyaxial and Malibu Reduction Screws. | Terminated | ||
| Z-1921-2009 | Malibu Polyaxial Screw, 6.5 x 45mm Part Number 12-6545 Malibu Spinal System when used as a Pedicle Screw Spinal System or Spondylolisthesis Spinal Fixation Device System is to provide immobilization in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine. | SeaSpine has received reports relating to rust on the internal washer contained within the titanium seat assembly of certain Malibu Polyaxial and Malibu Reduction Screws. | Terminated | ||
| Z-1920-2009 | Malibu Polyaxial Screw, 6.5 x 40mm Part Number 12-6540 Malibu Spinal System when used as a Pedicle Screw Spinal System or Spondylolisthesis Spinal Fixation Device System is to provide immobilization in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine. | SeaSpine has received reports relating to rust on the internal washer contained within the titanium seat assembly of certain Malibu Polyaxial and Malibu Reduction Screws. | Terminated | ||
| Z-1919-2009 | Malibu Polyaxial Screw, 6.5 x 35mm Part Number 12-6535 Malibu Spinal System when used as a Pedicle Screw Spinal System or Spondylolisthesis Spinal Fixation Device System is to provide immobilization in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine. | SeaSpine has received reports relating to rust on the internal washer contained within the titanium seat assembly of certain Malibu Polyaxial and Malibu Reduction Screws. | Terminated | ||
| Z-1918-2009 | Malibu Polyaxial Screw, 4.5 x 30mm Part Number 12-4530 Malibu Spinal System when used as a Pedicle Screw Spinal System or Spondylolisthesis Spinal Fixation Device System is to provide immobilization in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine. | SeaSpine has received reports relating to rust on the internal washer contained within the titanium seat assembly of certain Malibu Polyaxial and Malibu Reduction Screws. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain