Company ยท US
Seaspine, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2003 to 2023. Name variants (Inc, Corp, punctuation) are merged.
33510(k) clearances (0 in 12 months)
11recalls (0 in 12 months)
11recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| KWP | Appliance, Fixation, Spinal Interlaminal | 13 |
| NKB | Thoracolumbosacral Pedicle Screw System | 7 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 5 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 4 |
| MNI | Orthosis, Spinal Pedicle Fixation | 3 |
| MQP | Spinal Vertebral Body Replacement Device | 2 |
| NQW | Orthosis, Spine, Plate, Laminoplasty, Metal | 2 |
| ETN | Stimulator, Nerve | 1 |
| MQV | Filler, Bone Void, Calcium Compound | 1 |
| MRW | System, Facet Screw Spinal Device | 1 |
| NKG | Posterior Cervical Screw System | 1 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | 1 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | 1 |
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | 1 |
| PEK | Spinous Process Plate | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 3, 2023 | K231654 | NorthStar OCT System Seaspine, Inc. | NKG |
| Oct 4, 2021 | K212135 | Dry DBM- A Putty Seaspine Corporation | MQV |
| Mar 23, 2015 | K150469 | Integra Laminoplasty System Seaspine, Inc. | NQW |
| Dec 18, 2014 | K142488 | SeaSpine Spacer System - (Hollywood, Pacifica, Redondo, Ventura) NanoMetalene, Cambria NanoMetalene , Vu aPOD-L NanoMeta Seaspine, Inc. | MAX |
| May 1, 2014 | K133418 | INTEGRA EXPANDABLE INTERVEREBRAL BODY FUSION DEVICE (IBD) SYSTEM Seaspine, Inc. | MAX |
| Nov 18, 2013 | K132859 | INTEGRA FACET FIXATION SYSTEM Seaspine, Inc. | MRW |
| Sep 4, 2013 | K121924 | INTEGRA INTERSPINOUS PROCESS SYSTEM Seaspine, Inc. | PEK |
| May 9, 2013 | K130830 | INTEGRA LAMINOPLASTY SYSTEM Seaspine, Inc. | NQW |
| Dec 12, 2012 | K122571 | MALIBU SPINAL SYSTEM WITH THE DAYTONA DEFORMITY SYSTEM Seaspine, Inc. | NKB |
| Jan 25, 2012 | K112206 | CARDIFF ANTERIOR CERVICAL PLATE SYSTEM Seaspine, Inc. | KWQ |
| Dec 28, 2011 | K111671 | SEASPINE MONOPOLAR PROBE SYSYEM Seaspine, Inc. | ETN |
| May 12, 2011 | K102026 | SEASPINE SPACER SYSTEM Seaspine, Inc. | MAX |
| Jan 27, 2011 | K103297 | REDONDO-L Seaspine, Inc. | MAX |
| Apr 13, 2010 | K092521 | ZUMA-C Seaspine, Inc. | OVE |
| Apr 9, 2009 | K082309 | CAMBRIA Seaspine, Inc. | ODP |
| Feb 2, 2009 | K083338 | CARDIFF ANTERIOR CERVICAL PLATE SYSTEM Seaspine, Inc. | KWQ |
| Jan 13, 2009 | K083089 | NEWPORT SPINAL SYSTEM Seaspine, Inc. | NKB |
| Dec 22, 2008 | K082926 | ZUMA, MODEL 55-XXXX/56-XXXX Seaspine, Inc. | OVD |
| Nov 10, 2008 | K082310 | HOLLYWOOD, PACIFICA, REDONDO, VENTURA Seaspine, Inc. | MAX |
| Apr 17, 2008 | K072729 | SIERRA Seaspine, Inc. | KWP |
| Apr 16, 2008 | K080526 | SIERRA SYSTEM Seaspine, Inc. | KWP |
| Dec 20, 2007 | K072605 | MALIBU SPINAL SYSTEM Seaspine, Inc. | NKB |
| Oct 23, 2007 | K071726 | ZUMA Seaspine, Inc. | MQP |
| Nov 16, 2006 | K062934 | SIERRA Seaspine, Inc. | MNI |
| Oct 25, 2006 | K061342 | MALIBU SPINAL SYSTEM Seaspine, Inc. | NKB |
| Dec 21, 2005 | K052170 | SEASPINE VBR SYSTEM Seaspine, Inc. | MQP |
| Jul 27, 2005 | K051942 | MALIBU SPINAL SYSTEM Seaspine, Inc. | KWP |
| Jul 12, 2005 | K051663 | MALIBU SPINAL SYSTEM Seaspine, Inc. | NKB |
| Dec 21, 2004 | K043232 | UCR SPINAL SYSTEM Seaspine | NKB |
| Mar 26, 2004 | K040130 | ANTERIOR LUMBAR BUTTRESS SYSTEM Seaspine | KWQ |
| Nov 20, 2003 | K032739 | UCR SPINAL SYSTEM Seaspine | MNI |
| Oct 9, 2003 | K032368 | SONOMA ANTERIOR CERVICAL PLATE SYSTEM Seaspine | KWQ |
| Jul 30, 2003 | K031381 | UCR SPINAL SYSTEM, LAMINAR HOOKS, PEDICLE HOOKS, AND INSTRUMENTS Seaspine | MNI |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 20, 2014 | SeaSpine Inc 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 Terminated |
NKB | K043232 |
| Sep 3, 2009 | SeaSpine, Inc 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 immob Terminated |
KWP | K051942 |
| Sep 3, 2009 | SeaSpine, Inc 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 immob Terminated |
KWP | K051942 |
| Sep 3, 2009 | SeaSpine, Inc 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 immob Terminated |
KWP | K051942 |
| Sep 3, 2009 | SeaSpine, Inc 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 Terminated |
KWP | K051942 |
| Sep 3, 2009 | SeaSpine, Inc 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 Terminated |
KWP | K051942 |
| Sep 3, 2009 | SeaSpine, Inc 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 Terminated |
KWP | K051942 |
| Sep 3, 2009 | SeaSpine, Inc 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 Terminated |
KWP | K051942 |
| Sep 3, 2009 | SeaSpine, Inc 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 Terminated |
KWP | K051942 |
| Sep 3, 2009 | SeaSpine, Inc 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 Terminated |
KWP | K051942 |
| Sep 3, 2009 | SeaSpine, Inc 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 Terminated |
KWP | K051942 |