Data / Medical devices / United States / Seaspine Orthopedics Corporation
Seaspine Orthopedics Corporation: FDA-registered device maker in Carlsbad, CA, United States, 115 510(k) clearances
Seaspine Orthopedics Corporation is registered with the FDA (registration 3012120772) in Carlsbad, CA, United States. It lists 51 device types. The FDA files 115 510(k) clearances under its listings, the newest dated June 18, 2025. 9 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3012120772
- Address
- 5770 Armada Dr, Carlsbad, CA, United States, 92008
- Owner or operator
- SeaSpine Orthopedics Corporation (10049589)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- June 28, 2015
- Registered through
- 2027
- Brand names listed
- Admiral ACP System, Anterior Disc Prep, Anterior Disc Prep System, Atoll OCT Spinal System, Balboa, Balboa Anterior Lumbar Buttress System, BodyForm System, Bodyform Thoracic Fixation System and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Appliance, Fixation, Spinal Interlaminal | KWP | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Awl | HWJ | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Bender | HXW | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Bit, Drill | HTW | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Bone Fixation Cerclage, Sublaminar | OWI | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Brace, Drill | HXY | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Curette | HTF | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Curette, Surgical, General Use | FZS | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Cutter, Surgical | FZT | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Cutter, Wire | HXZ | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Extractor | HWB | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Forceps | HTD | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Fork | HXE | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Gauge, Depth | HTJ | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Growing Rod System | PGM | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Guide, Surgical, Instrument | FZX | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Hammer, Surgical | FZY | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Hook, Surgical, General & Plastic Surgery | GDG | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Impactor | HWA | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Instrument, Bending Or Contouring | HXP | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Instrument, Compression | HWN | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Intervertebral Fusion Device With Bone Graft, Thoracic | PHM | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Intervertebral Fusion Device With Integrated Fixation, Cervical | OVE | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Intervertebral Fusion Device With Integrated Fixation, Lumbar | OVD | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Orthopedic Manual Surgical Instrument | LXH | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Orthopedic Stereotaxic Instrument | OLO | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Orthopedic Tray | OJH | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Orthosis, Spinal Pedicle Fixation | MNI | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Orthosis, Spine, Plate, Laminoplasty, Metal | NQW | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Osteotome, Manual | GFI | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis | OSH | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Posterior Cervical Screw System | NKG | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Probe | HXB | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Rasp | HTR | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Retractor | GAD | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Rongeur | HTX | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Screwdriver | HXX | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Spinal Vertebral Body Replacement Device | MQP | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Spinous Process Plate | PEK | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Starter, Bone Screw | HWD | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| System, Facet Screw Spinal Device | MRW | U | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Tamp | HXG | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Tap, Bone | HWX | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Template | HWT | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Thoracolumbosacral Pedicle Screw System | NKB | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Twister, Wire | HXS | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Wrench | HXC | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance. Newest 100 of 115.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 18, 2025 | K250908 | Virata Spinal Fixation System | NKB | Substantially Equivalent | SeaSpine Orthopedics Corporation | accessdata.fda.gov |
| June 20, 2024 | K241466 | Shoreline ACS Interbody System; Shoreline RT Interbody System; Regatta Lateral System; Reef L Interbody System; Reef TO/TA System; Meridian Interbody System; WaveForm C Interbody System; WaveForm L Interbody System; WaveForm TO Interbody System; WaveForm TA Interbody System; WaveForm A Interbody System | MAX | Substantially Equivalent | SeaSpine Orthopedics Corporation | accessdata.fda.gov |
| June 20, 2024 | K240830 | Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody System; WaveForm TO Interbody System; WaveForm TA Interbody System; FORZA XP Expandable Spacer System; Shoreline ACS Interbody System; Shoreline RT Interbody System; Meridian Interbody System; WaveForm A Interbody System | MAX | Substantially Equivalent | Orthofix Medical, Inc. | accessdata.fda.gov |
| April 26, 2024 | K240566 | Reef L Interbody System; WaveForm L Interbody System | MAX | Substantially Equivalent | SeaSpine Orthopedics Corporation | accessdata.fda.gov |
| April 19, 2024 | K232566 | NewPort Spinal System; Daytona Small Stature Spinal System; Malibu Spinal System; Mariner Pedicle Screw Systems: Mariner Outrigger Revision System; Mariner MIS Pedicle Screw System; Mariner Deformity System; Mariner RDX System | NKB | Substantially Equivalent | SeaSpine Orthopedics Corporation | accessdata.fda.gov |
| January 12, 2024 | K233694 | Meridian Interbody System; WaveForm A Interbody System | MAX | Substantially Equivalent | SeaSpine Orthopedics Corporation | accessdata.fda.gov |
| November 28, 2023 | K233414 | Shoreline ACS Interbody System; Shoreline RT Interbody System | OVE | Substantially Equivalent | SeaSpine Orthopedics Corporation | accessdata.fda.gov |
| August 3, 2023 | K231654 | NorthStar OCT System | NKG | Substantially Equivalent | Seaspine, Inc. | accessdata.fda.gov |
| February 3, 2023 | K220296 | Manta Ray TDF Spacer | ODP | Substantially Equivalent | SeaSpine Orthopedics Corporation | accessdata.fda.gov |
| November 7, 2022 | K222732 | WaveForm A Interbody System | MAX | Substantially Equivalent | SeaSpine Orthopedics Corporation | accessdata.fda.gov |
| September 7, 2022 | K222110 | Mariner RDX System | NKB | Substantially Equivalent | SeaSpine Orthopedics Corporation | accessdata.fda.gov |
| May 10, 2022 | K220711 | SeaSpine Meridian System, SeaSpine Meridian Anterior Plate System | MAX | Substantially Equivalent | SeaSpine Orthopedics Corporation | accessdata.fda.gov |
| May 4, 2022 | K213420 | WaveForm L System, WaveForm TO System, WaveForm TA System | MAX | Substantially Equivalent | SeaSpine Orthopedics Corporation | accessdata.fda.gov |
| December 14, 2021 | K212904 | SeaSpine WaveForm C Interbody System | OVE | Substantially Equivalent | SeaSpine Orthopedics Corporation | accessdata.fda.gov |
| December 9, 2021 | K213359 | SeaSpine WaveForm, C Interbody System | OVE | Substantially Equivalent | SeaSpine Orthopedics Corporation | accessdata.fda.gov |
| September 21, 2021 | K212692 | Mariner Pedicle Screw System | NKB | Substantially Equivalent | SeaSpine Orthopedics Corporation | accessdata.fda.gov |
| September 10, 2021 | K212540 | Explorer TO System | MAX | Substantially Equivalent | SeaSpine Orthopedics Corporation | accessdata.fda.gov |
| September 1, 2021 | K212139 | Admiral ACP System | KWQ | Substantially Equivalent | SeaSpine Orthopedics Corporation | accessdata.fda.gov |
| August 30, 2021 | K211903 | Shoreline Threaded TruProfile® Plate | KWQ | Substantially Equivalent | SeaSpine Orthopedics Corporation | accessdata.fda.gov |
| July 7, 2021 | K210497 | SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu aPOD-L NanoMetalene, SeaSpine Vu ePOD System, SeaSpine Vu aPOD Prime NanoMetalene Intervertebral, SeaSpine Shoreline ACS - Anterior Cervical Standalone, SeaSpine Cervical Interbody RT System, SeaSpine Cambria System, SeaSpine Regatta Lateral System, SeaSpine Reef TO/TA System, SeaSpine Reef TH System, SeaSpine Meridian System | MAX | Substantially Equivalent | SeaSpine Orthopedics Corporation | accessdata.fda.gov |
| June 23, 2021 | K211606 | Mariner Deformity System | NKB | Substantially Equivalent | SeaSpine Orthopedics Corporation | accessdata.fda.gov |
| June 2, 2021 | K210583 | SeaSpine WaveForm A Interbody System | MAX | Substantially Equivalent | SeaSpine Orthopedics Corporation | accessdata.fda.gov |
| December 15, 2020 | K201755 | WaveForm L Interbody System, WaveForm TO Interbody System, WaveForm TA Interbody System | MAX | Substantially Equivalent | SeaSpine Orthopedics Corporation | accessdata.fda.gov |
| November 25, 2020 | K201193 | SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu aPOD-L NanoMetalene; SeaSpine Vu ePOD System; and SeaSpine Reef TH System, SeaSpine Vu aPOD Prime NanoMetalene IBD; and SeaSpine Shoreline ACS, SeaSpine Cambria System; SeaSpine Regatta Lateral System; and SeaSpine Meridian System, Shoreline Cervical Interbody RT System; and SeaSpine Beachside System | MAX | Substantially Equivalent | SeaSpine Orthopedics Corporation | accessdata.fda.gov |
| September 18, 2020 | K201073 | Seaspine WaveForm C Interbody System | OVE | Substantially Equivalent | SeaSpine Orthopedics Corporation | accessdata.fda.gov |
| September 14, 2020 | K201646 | Shoreline ACS (Anterior Cervical System) | OVE | Substantially Equivalent | SeaSpine Orthopedics Corporation | accessdata.fda.gov |
| August 26, 2020 | K202064 | Admiral ACP System | KWQ | Substantially Equivalent | SeaSpine Orthopedics Corporation | accessdata.fda.gov |
| August 5, 2020 | K201240 | Mariner Cap System | OWI | Substantially Equivalent | SeaSpine Orthopedics Corporation | accessdata.fda.gov |
| June 10, 2020 | K200879 | SeaSpine Meridian System, SeaSpine Regatta Lateral System | MAX | Substantially Equivalent | SeaSpine Orthopedics Corporation | accessdata.fda.gov |
| May 28, 2020 | K200885 | Meridian Anterior Plate System, Regatta Lateral Plate System | KWQ | Substantially Equivalent | SeaSpine Orthopedics Corporation | accessdata.fda.gov |
| April 24, 2020 | K193636 | SeaSpine Reef TH System | MAX | Substantially Equivalent | SeaSpine Orthopedics Corporation | accessdata.fda.gov |
| March 25, 2020 | K193615 | NorthStar OCT Spinal System | NKG | Substantially Equivalent | SeaSpine Orthopedics Corporation | accessdata.fda.gov |
| March 13, 2020 | K193418 | SeaSpine Skipjack System | MAX | Substantially Equivalent | SeaSpine Orthopedics Corporation | accessdata.fda.gov |
| February 28, 2020 | K200381 | Daytona® Small Stature Spinal System | NKB | Substantially Equivalent | SeaSpine Orthopedics Corporation | accessdata.fda.gov |
| February 13, 2020 | K193224 | Daytona® Small Stature Growth Rod Conversion Set | PGM | Substantially Equivalent | SeaSpine Orthopedics Corporation | accessdata.fda.gov |
| December 3, 2019 | K192132 | SeaSpine Beachside System | MAX | Substantially Equivalent | SeaSpine Orthopedics Corporation | accessdata.fda.gov |
| July 19, 2019 | K191648 | Mariner MIS Pedicle Screw System; SeaSpine Navigation System | NKB | Substantially Equivalent | SeaSpine Orthopedics Corporation | accessdata.fda.gov |
| May 23, 2019 | K183639 | Mariner Outrigger Revision System | NKB | Substantially Equivalent | SeaSpine Orthopedics Corporation | accessdata.fda.gov |
| April 29, 2019 | K190655 | SeaSpine® Shoreline ACS- Anterior Cervical Standalone System | OVE | Substantially Equivalent | SeaSpine Orthopedics Corporation | accessdata.fda.gov |
| February 14, 2019 | K183083 | Shoreline Cervical Interbody RT System | ODP | Substantially Equivalent | SeaSpine Orthopedics Corporation | accessdata.fda.gov |
| July 18, 2018 | K181079 | SeaSpine Regatta Lateral System | MAX | Substantially Equivalent | SeaSpine Orthopedics Corporation | accessdata.fda.gov |
| May 14, 2018 | K180686 | SeaSpine Daytona Small Stature Spinal System | NKB | Substantially Equivalent | SeaSpine Orthopedics Corporation | accessdata.fda.gov |
| May 11, 2018 | K172517 | SeaSpine Navigation System | OLO | Substantially Equivalent | SeaSpine Orthopedics Corporation | accessdata.fda.gov |
| April 13, 2018 | K173606 | SeaSpine Vu aPOD Prime NanoMetalene Intervertebral Body Fusion Device, SeaSpine Vu aPOD Prime Intervertebral Body Fusion Device | OVD | Substantially Equivalent | SeaSpine Orthopedics Corporation | accessdata.fda.gov |
| February 22, 2018 | K173334 | SeaSpine Spinous Process System | PEK | Substantially Equivalent | SeaSpine Orthopedics Corporation | accessdata.fda.gov |
| February 20, 2018 | K180176 | SeaSpine NewPort Spinal System | NKB | Substantially Equivalent | SeaSpine Orthopedics Corporation | accessdata.fda.gov |
| February 6, 2018 | K173882 | SeaSpine Mariner Pedicle Screw System | NKB | Substantially Equivalent | SeaSpine Orthopedics Corporation | accessdata.fda.gov |
| January 24, 2018 | K173521 | SeaSpine Cabo ACP (Anterior Cervical Plate) System | KWQ | Substantially Equivalent | SeaSpine Orthopedics Corporation | accessdata.fda.gov |
| October 26, 2017 | K173022 | SeaSpine Ventura NanoMetalene System | MAX | Substantially Equivalent | SeaSpine Orthopedics Corporation | accessdata.fda.gov |
| July 7, 2017 | K171046 | SeaSpine Cambria System | ODP | Substantially Equivalent | SeaSpine Orthopedics Corporation | accessdata.fda.gov |
| June 15, 2017 | K170569 | SeaSpine Shoreline ACS - Anterior Cervical Standalone System | OVE | Substantially Equivalent | SeaSpine Orthopedics Corporation | accessdata.fda.gov |
| March 9, 2017 | K163604 | SeaSpine® Daytona® Small Stature Spinal System | NKB | Substantially Equivalent | SeaSpine Orthopedics Corporation | accessdata.fda.gov |
| December 1, 2016 | K162351 | SeaSpine® Vu aPOD Prime NanoMetalene® Intervertebral Body Fusion Device | OVD | Substantially Equivalent | SeaSpine Orthopedics Corporation | accessdata.fda.gov |
| October 28, 2016 | K162715 | SeaSpine Spacer System- Hollywood NanoMetalene, Hollywood VI NanoMetalene, Ventura NanoMetalene; SeaSpine Cambria NanoMetalene | MAX | Substantially Equivalent | SeaSpine Orthopedics Corporation | accessdata.fda.gov |
| September 14, 2016 | K161081 | SeaSpine Shoreline ACS - Anterior Cervical Standalone System | OVE | Substantially Equivalent | SeaSpine Orthopedics Corporation | accessdata.fda.gov |
| September 8, 2016 | K161535 | SeaSpine® NewPort Spinal System | NKB | Substantially Equivalent | SeaSpine Orthopedics Corporation | accessdata.fda.gov |
| July 11, 2016 | K153786 | PROW FUSION-V | MAX | Substantially Equivalent | Nlt Spine, Ltd. | accessdata.fda.gov |
| May 26, 2016 | K160902 | Mariner Pedicle Screw System | NKB | Substantially Equivalent | SeaSpine Orthopedics Corporation | accessdata.fda.gov |
| March 23, 2015 | K150469 | Integra Laminoplasty System | NQW | Substantially Equivalent | Seaspine, Inc. | accessdata.fda.gov |
| December 18, 2014 | K142488 | SeaSpine Spacer System - (Hollywood, Pacifica, Redondo, Ventura) NanoMetalene, Cambria NanoMetalene , Vu aPOD-L NanoMetalene, Vu ePOD NanoMetalene | MAX | Substantially Equivalent | Seaspine, Inc. | accessdata.fda.gov |
| May 1, 2014 | K133418 | INTEGRA EXPANDABLE INTERVEREBRAL BODY FUSION DEVICE (IBD) SYSTEM | MAX | Substantially Equivalent | Seaspine, Inc. | accessdata.fda.gov |
| November 18, 2013 | K132859 | INTEGRA FACET FIXATION SYSTEM | MRW | Substantially Equivalent | Seaspine, Inc. | accessdata.fda.gov |
| September 4, 2013 | K121924 | INTEGRA INTERSPINOUS PROCESS SYSTEM | PEK | Substantially Equivalent | Seaspine, Inc. | accessdata.fda.gov |
| May 9, 2013 | K130830 | INTEGRA LAMINOPLASTY SYSTEM | NQW | Substantially Equivalent | Seaspine, Inc. | accessdata.fda.gov |
| December 12, 2012 | K122571 | MALIBU SPINAL SYSTEM WITH THE DAYTONA DEFORMITY SYSTEM | NKB | Substantially Equivalent | Seaspine, Inc. | accessdata.fda.gov |
| June 27, 2012 | K121211 | VU APOD INTERVERTEBRAL BODY FUSION DEVICE | OVD | Substantially Equivalent | Theken Spine, LLC | accessdata.fda.gov |
| May 30, 2012 | K120829 | STAINLESS STEEL SPINAL SYSTEM | NKB | Substantially Equivalent | Theken Spine, LLC | accessdata.fda.gov |
| May 1, 2012 | K112986 | LATERAL FUSION DEVICE | MAX | Substantially Equivalent | Integra Spine (Integra Lifesciences) | accessdata.fda.gov |
| February 3, 2012 | K120047 | CORAL SPINAL SYSTEM | NKB | Substantially Equivalent | Theken Spine, LLC | accessdata.fda.gov |
| August 2, 2011 | K111675 | VU C*POD INTERVERTEBRAL BODY FUSION DEVICE | ODP | Substantially Equivalent | Theken Spine, LLC | accessdata.fda.gov |
| May 12, 2011 | K102026 | SEASPINE SPACER SYSTEM | MAX | Substantially Equivalent | Seaspine, Inc. | accessdata.fda.gov |
| January 27, 2011 | K103297 | REDONDO-L | MAX | Substantially Equivalent | Seaspine, Inc. | accessdata.fda.gov |
| January 5, 2011 | K103228 | PARAMOUNT R IBF DEVICE | MAX | Substantially Equivalent | Theken Spine, LLC | accessdata.fda.gov |
| December 16, 2010 | K102323 | CERVICAL STANDALONE INTERVERTEBRAL BODY FUSION DEVICE | OVE | Substantially Equivalent | Theken Spine, LLC | accessdata.fda.gov |
| December 16, 2010 | K101363 | VU CPOD INTERVERTEBRAL BODU FUSION DEVICE | ODP | Substantially Equivalent | Musculoskeletal Clinical Regulatory Advisers | accessdata.fda.gov |
| September 2, 2010 | K101310 | VU APOD INTERVERTEBRAL BODY FUSION DEVICE | OVD | Substantially Equivalent | Theken Spine, LLC | accessdata.fda.gov |
| August 12, 2010 | K100970 | STAINLESS STEEL SPINAL SYSTEM | NKB | Substantially Equivalent | Theken Spine, LLC | accessdata.fda.gov |
| April 13, 2010 | K092521 | ZUMA-C | OVE | Substantially Equivalent | Seaspine, Inc. | accessdata.fda.gov |
| June 10, 2009 | K091266 | THEKEN CORAL SPINAL SYSTEM | NKB | Substantially Equivalent | Theken Spine, LLC | accessdata.fda.gov |
| April 9, 2009 | K082309 | CAMBRIA | ODP | Substantially Equivalent | Seaspine, Inc. | accessdata.fda.gov |
| March 27, 2009 | K083863 | THEKEN ATOLL OCT SPINAL SYSTEM | MNI | Substantially Equivalent | Theken Spine, LLC | accessdata.fda.gov |
| March 13, 2009 | K083073 | THEKEN ATOLL CERVICO-THORACIC SYSTEM | MNI | Substantially Equivalent | Theken Spine, LLC | accessdata.fda.gov |
| January 13, 2009 | K083089 | NEWPORT SPINAL SYSTEM | NKB | Substantially Equivalent | Seaspine, Inc. | accessdata.fda.gov |
| January 2, 2009 | K082712 | THEKEN SPINE VU EPOD AND VU LPOD SYSTEM | MAX | Substantially Equivalent | Theken Spine, LLC | accessdata.fda.gov |
| December 22, 2008 | K082926 | ZUMA, MODEL 55-XXXX/56-XXXX | OVD | Substantially Equivalent | Seaspine, Inc. | accessdata.fda.gov |
| November 10, 2008 | K082310 | HOLLYWOOD, PACIFICA, REDONDO, VENTURA | MAX | Substantially Equivalent | Seaspine, Inc. | accessdata.fda.gov |
| July 2, 2008 | K080822 | VU APOD INTERVERTABRAL BODY FUSION DEVICE | OVD | Substantially Equivalent | Theken Spine, LLC | accessdata.fda.gov |
| June 17, 2008 | K081414 | MODIFICATION TO CORAL SPINAL SYSTEM | NKB | Substantially Equivalent | Theken Spine, LLC | accessdata.fda.gov |
| April 29, 2008 | K080790 | MODIFICATION TO THEKEN ATOLL CERVICO-THORACIC SYSTEM | KWP | Substantially Equivalent | Theken Spine, LLC | accessdata.fda.gov |
| April 25, 2008 | K080690 | MANTA RAY ANTERIOR CERVICAL PLATE SYSTEM | KWQ | Substantially Equivalent | Theken Spine, LLC | accessdata.fda.gov |
| April 17, 2008 | K072729 | SIERRA | KWP | Substantially Equivalent | Seaspine, Inc. | accessdata.fda.gov |
| April 16, 2008 | K080526 | SIERRA SYSTEM | KWP | Substantially Equivalent | Seaspine, Inc. | accessdata.fda.gov |
| December 21, 2007 | K072407 | BODYFORM THORACIC FIXATION SYSTEM | KWQ | Substantially Equivalent | Theken Spine, LLC | accessdata.fda.gov |
| December 20, 2007 | K072605 | MALIBU SPINAL SYSTEM | NKB | Substantially Equivalent | Seaspine, Inc. | accessdata.fda.gov |
| November 28, 2007 | K072650 | IST ANTERIOR CERVICAL PLATE SYSTEM | KWQ | Substantially Equivalent | Innovative Spinal Technologies, Inc. | accessdata.fda.gov |
| October 23, 2007 | K071726 | ZUMA | MQP | Substantially Equivalent | Seaspine, Inc. | accessdata.fda.gov |
| August 22, 2007 | K070962 | CORAL PEDICLE SCREW SYSTEM | NKB | Substantially Equivalent | Theken Spine, LLC | accessdata.fda.gov |
| July 30, 2007 | K071031 | VU E*POD VERTEBRAL BODY REPLACEMENT | MQP | Substantially Equivalent | Theken Spine, LLC | accessdata.fda.gov |
| May 30, 2007 | K070638 | THEKEN ATOLL CERVICO-THORACIC SYSTEM | KWP | Substantially Equivalent | Theken Spine, LLC | accessdata.fda.gov |
| April 25, 2007 | K070381 | THEKEN VU MESH VBR SYSTEM | MQP | Substantially Equivalent | Theken Spine, LLC | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| August 19, 2026 | 99691 | Class II | Ongoing | SeaSpine Mariner Deformity Product Name: Extended Polyaxial Head, Attached Gimbal, 12mm REF: MD1-300010-12 | The proximal thread depth of the spinal device is out of design specification. | accessdata.fda.gov |
| May 28, 2026 | 99221 | Class II | Ongoing | SeaSpine Polyaxial Head REF Number: 41-3010 | Due to manufacturing error, polyaxial head may popoff from the screw intraoperatively following insertion. | accessdata.fda.gov |
| November 17, 2025 | 97973 | Class II | Ongoing | Orthofix NorthStar OCT Navigation Surgical Technique Guide, and instruments: Navigation Driver, REF: PC2-400012; Navigation Straight Bone Probe, REF: PC2-400013; Navigation, 3.5mm Drill, REF: PC2-400135; Navigation, 4.0m | The NorthStar OCT Navigation Surgical Technique Guide (STG) incorrectly identified both Medtronic s Solera and Medtronic s Infinity system toolcards as compatible with the NorthStar OCT Navigation Instruments. However, the NorthStar OCT Navigation Instruments are compatible for use with Medtronic s Solera toolcards only. | accessdata.fda.gov |
| August 6, 2025 | 97190 | Class II | Ongoing | Reef TA Inserter, Part Number: TA2-001003, part of the Reef Interbody System | Inserter, used as part of a system with an intervertebral body fusion device, may contribute to difficulty disengaging the implant or improper implant positioning, which may may lead to prolonged surgery, intraoperative revision, and may require the use of alternate instrumentation. Devices may also have incorrect UDI-DI marking. | accessdata.fda.gov |
| October 29, 2024 | 95760 | Class II | Ongoing | Brand Name: Daytona Small Stature Product Name: CoCr LockingCap 4.5mm, Small Stature, T25, BT Model/Catalog Number: 79-0002 Software Version: N/A Product Description: Locking Cap Component: No | Due to manufacturing defects observed on Locking Caps that affect the ability for components to mate. | accessdata.fda.gov |
| June 4, 2024 | 94872 | Class II | Ongoing | Brand Name: Meridian Angled Awl Fixed Product Name: Angled Awl Fixed Model/Catalog Number: RA2-003015 Product Description: Surgical Awl Component: No | Insufficient weld around the cap component of the instrument is insufficient to withstand impaction forces. | accessdata.fda.gov |
| May 17, 2024 | 94745 | Class II | Ongoing | Brand Name: Fathom Pedicle-Based Retractor Product Name: C/C Blade, 35-55mm Model/Catalog Number: MR2102035 Product Description: Cranial Caudal Blade Component: Yes, a component of a retractor blade | Cranial Caudal Blades manufactured incorrectly could result in fracture and/or damage to the bone structure | accessdata.fda.gov |
| February 28, 2024 | 94306 | Class II | Ongoing | Mariner RDX MIS Polyaxial Head, REF: MX1-001010, part of Mariner RDX MIS Alpha Instruments and Implants, REF: AMRDXMIS, which are pedicle screw systems. | Screw heads, of pedicle screw systems, have partial thread within the screw head that pose a risk of intraoperative cross-threading within the locking cap/screw head interface. | accessdata.fda.gov |
| February 15, 2024 | 94164 | Class II | Ongoing | Mariner RDX Polyaxial Head, REF: MX1-000020; Mariner RDX Extended Polyaxial Head, REF: MX1-000030; Mariner RDX Deformity Head, REF: MX1-000040; Mariner RDX Extended Deformity Head, REF: MX1-000050; Mariner RDX Trauma Hea | Screw heads, of pedicle screw systems, have thin lead-in thread that pose a risk of intraoperative cross-threading within the locking cap/screw head interface. | accessdata.fda.gov |
Compare with other makers
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- All makers of Intervertebral Fusion Device With Integrated Fixation, Lumbar
- All makers of Intervertebral Fusion Device With Integrated Fixation, Cervical
Updated September 18, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.