SeaSpine Orthopedics Corporation: FDA clearances and approvals
SeaSpine Orthopedics Corporation has 67 FDA 510(k) clearances (first 2016, latest 2026), across 12 product codes in 1 review panel. Median 510(k) review time: 85 days. Since 2017 its median was 84 days, against 90 days for all cleared 510(k)s in the same product codes. openFDA lists 11 product recalls by a recalling firm named SeaSpine Orthopedics Corporation.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2016 | 5 | 97 |
| 2017 | 7 | 87 |
| 2018 | 8 | 78 |
| 2019 | 6 | 73 |
| 2020 | 14 | 90 |
| 2021 | 9 | 58 |
| 2022 | 5 | 60 |
| 2023 | 5 | 156 |
| 2024 | 5 | 56 |
| 2025 | 2 | 105 |
| 2026 | 1 | 273 |
Review time against the same product codes
Since 2017, SeaSpine Orthopedics Corporation's cleared 510(k)s took a median 84 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 90 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 20 | 20 |
| NKB | Thoracolumbosacral Pedicle Screw System | 14 | 14 |
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | 8 | 8 |
| MQV | Filler, Bone Void, Calcium Compound | 7 | 7 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 5 | 5 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | 4 | 4 |
| OLO | Orthopedic Stereotaxic Instrument | 3 | 3 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | 2 | 2 |
| NKG | Posterior Cervical Screw System | 1 | 1 |
| OWI | Bone Fixation Cerclage, Sublaminar | 1 | 1 |
Plus 2 more product codes.
Review panels
- Orthopedic (67)
Most recent SeaSpine Orthopedics Corporation 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K253420 | Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer; Meridian Interbody System; Meridian Anterior Plate System; Reef L Interbody System; Reef TO/TA System; Regatta Lateral System; Regatta Lateral Plate System; Shoreline ACS Interbody System; Shoreline Threaded TruProfile Plate; Shoreline RT Interbody System; Vu Mesh; WaveForm A Interbody System; WaveForm C Interbody System; WaveForm L Interbody System; WaveForm TA Interbody System; WaveForm TO Interbody Sy | MAX | 2026-07-01 | 273 |
| K250908 | Virata Spinal Fixation System | NKB | 2025-06-18 | 84 |
| K243659 | FLASH Facet Fusion Instruments, IsoTis® Facet Fusion Instruments | OLO | 2025-04-02 | 126 |
| K242273 | Cove Putty, OsteoCove Putty | MQV | 2024-09-25 | 55 |
| 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 | 2024-06-20 | 28 |
| K240566 | Reef L Interbody System; WaveForm L Interbody System | MAX | 2024-04-26 | 57 |
| 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 | 2024-04-19 | 239 |
| K233694 | Meridian Interbody System; WaveForm A Interbody System | MAX | 2024-01-12 | 56 |
| K233414 | Shoreline ACS Interbody System; Shoreline RT Interbody System | OVE | 2023-11-28 | 49 |
| K232668 | Cove Strip, OsteoCove Strip | MQV | 2023-09-27 | 26 |
57 earlier clearances. See the full list in Caduvo.
Recalls
11 product recalls in 9 recall events; 11 initiated in the last five years. Most recent: 2026-08-19.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does SeaSpine Orthopedics Corporation have?
SeaSpine Orthopedics Corporation has 67 FDA 510(k) clearances (first 2016, latest 2026), across 12 product codes in 1 review panel.
How long does FDA take to clear SeaSpine Orthopedics Corporation's 510(k)s?
The median time from FDA receipt to decision across SeaSpine Orthopedics Corporation's cleared 510(k)s is 85 days. Since 2017: 84 days, versus 90 days for all cleared 510(k)s in the same product codes.
What devices does SeaSpine Orthopedics Corporation make?
Its most frequent FDA product codes are MAX (Intervertebral Fusion Device With Bone Graft, Lumbar, 20); NKB (Thoracolumbosacral Pedicle Screw System, 14); OVE (Intervertebral Fusion Device With Integrated Fixation, Cervical, 8).
Has SeaSpine Orthopedics Corporation had device recalls?
openFDA lists 11 product recalls in 9 recall events by a recalling firm whose name matches SeaSpine Orthopedics Corporation; the most recent began 2026-08-19. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 67 SeaSpine Orthopedics Corporation clearances with predicates and recalls
- Run predicate analysis for product code MAX, SeaSpine Orthopedics Corporation's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.