SEASPINE ORTHOPEDICS CORPORATION
FDA Regulatory Profile
Summary
- Total Recalls
- 9
- 510(k) Clearances
- 66
- Inspections
- 2
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0937-2026 | Class II | Orthofix NorthStar OCT Navigation Surgical Technique Guide, and instruments: Navigation Driver, REF | November 17, 2025 |
| Z-2554-2025 | Class II | Reef TA Inserter, Part Number: TA2-001003, part of the Reef Interbody System | August 6, 2025 |
| Z-0752-2025 | Class II | Brand Name: Daytona Small Stature Product Name: Ti Locking Cap 4.5mm, Small Stature, T25 Model/Cat | October 29, 2024 |
| Z-0751-2025 | Class II | Brand Name: Daytona Small Stature Product Name: CoCr LockingCap 4.5mm, Small Stature, T25, BT Mode | October 29, 2024 |
| Z-2357-2024 | Class II | Brand Name: Meridian Angled Awl Fixed Product Name: Angled Awl Fixed Model/Catalog Number: RA2-003 | June 4, 2024 |
| Z-2234-2024 | Class II | Brand Name: Fathom Pedicle-Based Retractor Product Name: C/C Blade, 35-55mm Model/Catalog Number: | May 17, 2024 |
| Z-2235-2024 | Class II | Brand Name: Fathom Pedicle-Based Retractor Product Name: C/C Blade, 50-80mm Model/Catalog Number: | May 17, 2024 |
| Z-1620-2024 | Class II | Mariner RDX MIS Polyaxial Head, REF: MX1-001010, part of Mariner RDX MIS Alpha Instruments and Impla | February 28, 2024 |
| Z-1605-2024 | Class II | Mariner RDX Polyaxial Head, REF: MX1-000020; Mariner RDX Extended Polyaxial Head, REF: MX1-000030; | February 15, 2024 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K250908 | Virata Spinal Fixation System | June 18, 2025 |
| K243659 | FLASH Facet Fusion Instruments, IsoTis® Facet Fusion Instruments | April 2, 2025 |
| K242273 | Cove Putty, OsteoCove Putty | September 25, 2024 |
| K241466 | Shoreline ACS Interbody System; Shoreline RT Interbody System; Regatta Lateral System; Reef L Interb | June 20, 2024 |
| K240566 | Reef L Interbody System; WaveForm L Interbody System | April 26, 2024 |
| K232566 | NewPort Spinal System; Daytona Small Stature Spinal System; Malibu Spinal System; Mariner Pedicle Sc | April 19, 2024 |
| K233694 | Meridian Interbody System; WaveForm A Interbody System | January 12, 2024 |
| K233414 | Shoreline ACS Interbody System; Shoreline RT Interbody System | November 28, 2023 |
| K232668 | Cove Strip, OsteoCove Strip | September 27, 2023 |
| K231030 | Cove Putty, OsteoCove Putty | September 14, 2023 |
| K230486 | Cove Strip | August 21, 2023 |
| K220296 | Manta Ray TDF Spacer | February 3, 2023 |
| K222753 | SeaSpine 7D Navigation Instruments | December 9, 2022 |
| K222732 | WaveForm A Interbody System | November 7, 2022 |
| K222110 | Mariner RDX System | September 7, 2022 |
| K220711 | SeaSpine Meridian System, SeaSpine Meridian Anterior Plate System | May 10, 2022 |
| K213420 | WaveForm L System, WaveForm TO System, WaveForm TA System | May 4, 2022 |
| K212904 | SeaSpine WaveForm C Interbody System | December 14, 2021 |
| K213359 | SeaSpine WaveForm, C Interbody System | December 9, 2021 |
| K212692 | Mariner Pedicle Screw System | September 21, 2021 |