Company · US
SeaSpine Orthopedics Corporation
FDA 510(k) clearances and medical device recalls filed under this name, 2016 to 2026. Name variants (Inc, Corp, punctuation) are merged.
69510(k) clearances (3 in 12 months)
11recalls (3 in 12 months)
8recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 21 |
| NKB | Thoracolumbosacral Pedicle Screw System | 21 |
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | 8 |
| MQV | Filler, Bone Void, Calcium Compound | 7 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 5 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | 4 |
| OLO | Orthopedic Stereotaxic Instrument | 4 |
| GAD | Retractor | 2 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | 2 |
| HWJ | Awl | 1 |
| MQP | Spinal Vertebral Body Replacement Device | 1 |
| NKG | Posterior Cervical Screw System | 1 |
| OWI | Bone Fixation Cerclage, Sublaminar | 1 |
| PEK | Spinous Process Plate | 1 |
| PGM | Growing Rod System | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 29, 2026 | K262731 | Virata Spinal Fixation System SeaSpine Orthopedics Corporation | NKB |
| Oct 29, 2026 | K262574 | Convoy Expandable Corpectomy System SeaSpine Orthopedics Corporation | MQP |
| Jul 1, 2026 | K253420 | Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer; Meridian Interbody System; Meridian A SeaSpine Orthopedics Corporation | MAX |
| Jun 18, 2025 | K250908 | Virata Spinal Fixation System SeaSpine Orthopedics Corporation | NKB |
| Apr 2, 2025 | K243659 | FLASH Facet Fusion Instruments, IsoTis® Facet Fusion Instruments SeaSpine Orthopedics Corporation | OLO |
| Sep 25, 2024 | K242273 | Cove Putty, OsteoCove Putty SeaSpine Orthopedics Corporation | MQV |
| Jun 20, 2024 | K241466 | Shoreline ACS Interbody System; Shoreline RT Interbody System; Regatta Lateral System; Reef L Interbody System; Reef TO/ SeaSpine Orthopedics Corporation | MAX |
| Apr 26, 2024 | K240566 | Reef L Interbody System; WaveForm L Interbody System SeaSpine Orthopedics Corporation | MAX |
| Apr 19, 2024 | K232566 | NewPort Spinal System; Daytona Small Stature Spinal System; Malibu Spinal System; Mariner Pedicle Screw Systems: Mariner SeaSpine Orthopedics Corporation | NKB |
| Jan 12, 2024 | K233694 | Meridian Interbody System; WaveForm A Interbody System SeaSpine Orthopedics Corporation | MAX |
| Nov 28, 2023 | K233414 | Shoreline ACS Interbody System; Shoreline RT Interbody System SeaSpine Orthopedics Corporation | OVE |
| Sep 27, 2023 | K232668 | Cove Strip, OsteoCove Strip SeaSpine Orthopedics Corporation | MQV |
| Sep 14, 2023 | K231030 | Cove Putty, OsteoCove Putty SeaSpine Orthopedics Corporation | MQV |
| Aug 21, 2023 | K230486 | Cove Strip SeaSpine Orthopedics Corporation | MQV |
| Feb 3, 2023 | K220296 | Manta Ray TDF Spacer SeaSpine Orthopedics Corporation | ODP |
| Dec 9, 2022 | K222753 | SeaSpine 7D Navigation Instruments SeaSpine Orthopedics Corporation | OLO |
| Nov 7, 2022 | K222732 | WaveForm A Interbody System SeaSpine Orthopedics Corporation | MAX |
| Sep 7, 2022 | K222110 | Mariner RDX System SeaSpine Orthopedics Corporation | NKB |
| May 10, 2022 | K220711 | SeaSpine Meridian System, SeaSpine Meridian Anterior Plate System SeaSpine Orthopedics Corporation | MAX |
| May 4, 2022 | K213420 | WaveForm L System, WaveForm TO System, WaveForm TA System SeaSpine Orthopedics Corporation | MAX |
| Dec 14, 2021 | K212904 | SeaSpine WaveForm C Interbody System SeaSpine Orthopedics Corporation | OVE |
| Dec 9, 2021 | K213359 | SeaSpine WaveForm, C Interbody System SeaSpine Orthopedics Corporation | OVE |
| Sep 21, 2021 | K212692 | Mariner Pedicle Screw System SeaSpine Orthopedics Corporation | NKB |
| Sep 10, 2021 | K212540 | Explorer TO System SeaSpine Orthopedics Corporation | MAX |
| Sep 1, 2021 | K212139 | Admiral ACP System SeaSpine Orthopedics Corporation | KWQ |
| Aug 30, 2021 | K211903 | Shoreline Threaded TruProfile® Plate SeaSpine Orthopedics Corporation | KWQ |
| Jul 7, 2021 | K210497 | SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu aPOD-L NanoMetalene, SeaSpine Vu e SeaSpine Orthopedics Corporation | MAX |
| Jun 23, 2021 | K211606 | Mariner Deformity System SeaSpine Orthopedics Corporation | NKB |
| Jun 2, 2021 | K210583 | SeaSpine WaveForm A Interbody System SeaSpine Orthopedics Corporation | MAX |
| Dec 15, 2020 | K201755 | WaveForm L Interbody System, WaveForm TO Interbody System, WaveForm TA Interbody System SeaSpine Orthopedics Corporation | MAX |
| Nov 25, 2020 | K201193 | SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu aPOD-L NanoMetalene; SeaSpine Vu e SeaSpine Orthopedics Corporation | MAX |
| Sep 18, 2020 | K201073 | Seaspine WaveForm C Interbody System SeaSpine Orthopedics Corporation | OVE |
| Sep 14, 2020 | K201646 | Shoreline ACS (Anterior Cervical System) SeaSpine Orthopedics Corporation | OVE |
| Aug 26, 2020 | K202064 | Admiral ACP System SeaSpine Orthopedics Corporation | KWQ |
| Aug 5, 2020 | K201240 | Mariner Cap System SeaSpine Orthopedics Corporation | OWI |
| Jun 10, 2020 | K200879 | SeaSpine Meridian System, SeaSpine Regatta Lateral System SeaSpine Orthopedics Corporation | MAX |
| May 28, 2020 | K200885 | Meridian Anterior Plate System, Regatta Lateral Plate System SeaSpine Orthopedics Corporation | KWQ |
| May 11, 2020 | K200290 | Resorbable Mesh Pouch (Ballast MT, OsteoBallast MT) SeaSpine Orthopedics Corporation | MQV |
| Apr 24, 2020 | K193636 | SeaSpine Reef TH System SeaSpine Orthopedics Corporation | MAX |
| Mar 25, 2020 | K193615 | NorthStar OCT Spinal System SeaSpine Orthopedics Corporation | NKG |
| Mar 13, 2020 | K193418 | SeaSpine Skipjack System SeaSpine Orthopedics Corporation | MAX |
| Feb 28, 2020 | K200381 | Daytona® Small Stature Spinal System SeaSpine Orthopedics Corporation | NKB |
| Feb 13, 2020 | K193224 | Daytona® Small Stature Growth Rod Conversion Set SeaSpine Orthopedics Corporation | PGM |
| Dec 3, 2019 | K192132 | SeaSpine Beachside System SeaSpine Orthopedics Corporation | MAX |
| Nov 30, 2019 | K193040 | Resorbable Mesh Device SeaSpine Orthopedics Corporation | MQV |
| Jul 19, 2019 | K191648 | Mariner MIS Pedicle Screw System; SeaSpine Navigation System SeaSpine Orthopedics Corporation | NKB |
| May 23, 2019 | K183639 | Mariner Outrigger Revision System SeaSpine Orthopedics Corporation | NKB |
| Apr 29, 2019 | K190655 | SeaSpine® Shoreline ACS- Anterior Cervical Standalone System SeaSpine Orthopedics Corporation | OVE |
| Feb 14, 2019 | K183083 | Shoreline Cervical Interbody RT System SeaSpine Orthopedics Corporation | ODP |
| Jul 18, 2018 | K181079 | SeaSpine Regatta Lateral System SeaSpine Orthopedics Corporation | MAX |
Newest 50 of 69.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 18, 2026 | SEASPINE ORTHOPEDICS CORPORATION SeaSpine Mariner Deformity
Product Name: Extended Polyaxial Head, Attached Gimbal, 12mm
REF: MD1-300010-12 Open, Classified |
NKB | K211606 |
| Jul 20, 2026 | SEASPINE ORTHOPEDICS CORPORATION SeaSpine Polyaxial Head
REF Number: 41-3010 Open, Classified |
NKB | K173882 |
| Dec 17, 2025 | SEASPINE ORTHOPEDICS CORPORATION 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: PC2-4001 Open, Classified |
OLO | K172517 |
| Sep 11, 2025 | SEASPINE ORTHOPEDICS CORPORATION Reef TA Inserter, Part Number: TA2-001003, part of the Reef Interbody System Open, Classified |
MAX | K192132 |
| Dec 23, 2024 | SEASPINE ORTHOPEDICS CORPORATION Brand Name: Daytona Small Stature
Product Name: Ti Locking Cap 4.5mm, Small Stature, T25
Model/Catalog Number: 79-0001
Software Version: N/A
Product Description: Locking Cap
Component: No Open, Classified |
NKB | K232566 |
| Dec 23, 2024 | SEASPINE ORTHOPEDICS CORPORATION 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 Open, Classified |
NKB | K232566 |
| Jul 15, 2024 | SEASPINE ORTHOPEDICS CORPORATION Brand Name: Meridian Angled Awl Fixed
Product Name: Angled Awl Fixed
Model/Catalog Number: RA2-003015
Product Description: Surgical Awl
Component: No Open, Classified |
HWJ | None listed |
| Jun 28, 2024 | SEASPINE ORTHOPEDICS CORPORATION Brand Name: Fathom Pedicle-Based Retractor
Product Name: C/C Blade, 50-80mm
Model/Catalog Number: MR2102050
Product Description: Cranial Caudal Blade
Component: Yes, a component of a retractor blade Open, Classified |
GAD | None listed |
| Jun 28, 2024 | SEASPINE ORTHOPEDICS CORPORATION 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 Open, Classified |
GAD | None listed |
| Apr 23, 2024 | SEASPINE ORTHOPEDICS CORPORATION Mariner RDX MIS Polyaxial Head, REF: MX1-001010, part of Mariner RDX MIS Alpha Instruments and Implants, REF: AMRDXMIS, which are pedicle screw systems. Open, Classified |
NKB | K222110 |
| Apr 22, 2024 | SEASPINE ORTHOPEDICS CORPORATION 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;
Ma Open, Classified |
NKB | K222110 |