Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
SeaSpine Orthopedics Corporation · Predicate Candidate Screening
67 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
85 daysmedian FDA review time
179 days90th percentile
67clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253420 | Admiral ACP System; Explorer TO System; Laminoplasty System; | SeaSpine Orthopedics Corporation | 2026-07-01 | 273 | 0 |
| K250908 | Virata Spinal Fixation System | SeaSpine Orthopedics Corporation | 2025-06-18 | 84 | 1 |
| K243659 | FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion Instru | SeaSpine Orthopedics Corporation | 2025-04-02 | 126 | 0 |
| K242273 | Cove Putty, OsteoCove Putty | SeaSpine Orthopedics Corporation | 2024-09-25 | 55 | 2 |
| K241466 | Shoreline ACS Interbody System; Shoreline RT Interbody Syste | SeaSpine Orthopedics Corporation | 2024-06-20 | 28 | 0 |
| K240566 | Reef L Interbody System; WaveForm L Interbody System | SeaSpine Orthopedics Corporation | 2024-04-26 | 57 | 0 |
| K232566 | NewPort Spinal System; Daytona Small Stature Spinal System; | SeaSpine Orthopedics Corporation | 2024-04-19 | 239 | 2 |
| K233694 | Meridian Interbody System; WaveForm A Interbody System | SeaSpine Orthopedics Corporation | 2024-01-12 | 56 | 0 |
| K233414 | Shoreline ACS Interbody System; Shoreline RT Interbody Syste | SeaSpine Orthopedics Corporation | 2023-11-28 | 49 | 0 |
| K232668 | Cove Strip, OsteoCove Strip | SeaSpine Orthopedics Corporation | 2023-09-27 | 26 | 0 |
| K231030 | Cove Putty, OsteoCove Putty | SeaSpine Orthopedics Corporation | 2023-09-14 | 156 | 0 |
| K230486 | Cove Strip | SeaSpine Orthopedics Corporation | 2023-08-21 | 179 | 0 |
| K220296 | Manta Ray TDF Spacer | SeaSpine Orthopedics Corporation | 2023-02-03 | 366 | 0 |
| K222753 | SeaSpine 7D Navigation Instruments | SeaSpine Orthopedics Corporation | 2022-12-09 | 88 | 0 |
| K222732 | WaveForm A Interbody System | SeaSpine Orthopedics Corporation | 2022-11-07 | 59 | 0 |
| K222110 | Mariner RDX System | SeaSpine Orthopedics Corporation | 2022-09-07 | 51 | 2 |
| K220711 | SeaSpine Meridian System, SeaSpine Meridian Anterior Plate S | SeaSpine Orthopedics Corporation | 2022-05-10 | 60 | 0 |
| K213420 | WaveForm L System, WaveForm TO System, WaveForm TA System | SeaSpine Orthopedics Corporation | 2022-05-04 | 196 | 0 |
| K212904 | SeaSpine WaveForm C Interbody System | SeaSpine Orthopedics Corporation | 2021-12-14 | 92 | 0 |
| K213359 | SeaSpine WaveForm, C Interbody System | SeaSpine Orthopedics Corporation | 2021-12-09 | 58 | 0 |
| K212692 | Mariner Pedicle Screw System | SeaSpine Orthopedics Corporation | 2021-09-21 | 27 | 0 |
| K212540 | Explorer TO System | SeaSpine Orthopedics Corporation | 2021-09-10 | 29 | 0 |
| K212139 | Admiral ACP System | SeaSpine Orthopedics Corporation | 2021-09-01 | 55 | 0 |
| K211903 | Shoreline Threaded TruProfile® Plate | SeaSpine Orthopedics Corporation | 2021-08-30 | 70 | 0 |
| K210497 | SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica | SeaSpine Orthopedics Corporation | 2021-07-07 | 135 | 0 |
| K211606 | Mariner Deformity System | SeaSpine Orthopedics Corporation | 2021-06-23 | 29 | 0 |
| K210583 | SeaSpine WaveForm™ A Interbody System | SeaSpine Orthopedics Corporation | 2021-06-02 | 96 | 0 |
| K201755 | WaveForm L Interbody System, WaveForm TO Interbody System, W | SeaSpine Orthopedics Corporation | 2020-12-15 | 169 | 0 |
| K201193 | SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica | SeaSpine Orthopedics Corporation | 2020-11-25 | 205 | 0 |
| K201073 | Seaspine WaveForm C Interbody System | SeaSpine Orthopedics Corporation | 2020-09-18 | 149 | 0 |
| K201646 | Shoreline ACS (Anterior Cervical System) | SeaSpine Orthopedics Corporation | 2020-09-14 | 89 | 0 |
| K202064 | Admiral ACP System | SeaSpine Orthopedics Corporation | 2020-08-26 | 30 | 0 |
| K201240 | Mariner Cap System | SeaSpine Orthopedics Corporation | 2020-08-05 | 89 | 0 |
| K200879 | SeaSpine Meridian System, SeaSpine Regatta Lateral System | SeaSpine Orthopedics Corporation | 2020-06-10 | 69 | 0 |
| K200885 | Meridian Anterior Plate System, Regatta Lateral Plate System | SeaSpine Orthopedics Corporation | 2020-05-28 | 56 | 0 |
| K200290 | Resorbable Mesh Pouch (Ballast MT, OsteoBallast MT) | SeaSpine Orthopedics Corporation | 2020-05-11 | 96 | 0 |
| K193636 | SeaSpine Reef TH System | SeaSpine Orthopedics Corporation | 2020-04-24 | 119 | 0 |
| K193615 | NorthStar™ OCT Spinal System | SeaSpine Orthopedics Corporation | 2020-03-25 | 90 | 0 |
| K193418 | SeaSpine Skipjack System | SeaSpine Orthopedics Corporation | 2020-03-13 | 95 | 0 |
| K200381 | Daytona® Small Stature Spinal System | SeaSpine Orthopedics Corporation | 2020-02-28 | 10 | 0 |
| K193224 | Daytona® Small Stature Growth Rod Conversion Set | SeaSpine Orthopedics Corporation | 2020-02-13 | 83 | 0 |
| K192132 | SeaSpine Beachside System | SeaSpine Orthopedics Corporation | 2019-12-03 | 118 | 1 |
| K193040 | Resorbable Mesh Device | SeaSpine Orthopedics Corporation | 2019-11-30 | 30 | 0 |
| K191648 | Mariner MIS Pedicle Screw System; SeaSpine Navigation System | SeaSpine Orthopedics Corporation | 2019-07-19 | 29 | 0 |
| K183639 | Mariner Outrigger Revision System | SeaSpine Orthopedics Corporation | 2019-05-23 | 148 | 0 |
| K190655 | SeaSpine® Shoreline™ ACS- Anterior Cervical Standalone Syste | SeaSpine Orthopedics Corporation | 2019-04-29 | 46 | 0 |
| K183083 | Shoreline Cervical Interbody RT System | SeaSpine Orthopedics Corporation | 2019-02-14 | 100 | 0 |
| K181079 | SeaSpine Regatta Lateral System | SeaSpine Orthopedics Corporation | 2018-07-18 | 85 | 0 |
| K180686 | SeaSpine Daytona Small Stature Spinal System | SeaSpine Orthopedics Corporation | 2018-05-14 | 60 | 0 |
| K172517 | SeaSpine Navigation System | SeaSpine Orthopedics Corporation | 2018-05-11 | 263 | 1 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda