Seaspine, Inc.: FDA clearances and approvals
Seaspine, Inc. has 33 FDA 510(k) clearances (first 2003, latest 2023), across 15 product codes in 2 review panels. Median 510(k) review time: 89 days. openFDA lists 11 product recalls by a recalling firm named Seaspine, Inc. It is the industry lead sponsor of 3 device clinical trials on ClinicalTrials.gov.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 2 | 144 |
| 2013 | 3 | 67 |
| 2014 | 2 | 140 |
| 2015 | 1 | 28 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 1 | 88 |
| 2022 | 0 | — |
| 2023 | 1 | 58 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Seaspine, Inc.'s cleared 510(k)s took a median 73 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 |
|---|---|---|---|
| NKB | Thoracolumbosacral Pedicle Screw System | 6 | 6 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 5 | 5 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 4 | 4 |
| KWP | Appliance, Fixation, Spinal Interlaminal | 3 | 3 |
| MNI | Orthosis, Spinal Pedicle Fixation | 3 | 3 |
| MQP | Spinal Vertebral Body Replacement Device | 2 | 2 |
| NQW | Orthosis, Spine, Plate, Laminoplasty, Metal | 2 | 2 |
| ETN | Stimulator, Nerve | 1 | 1 |
| MQV | Filler, Bone Void, Calcium Compound | 1 | 1 |
| MRW | System, Facet Screw Spinal Device | 1 | 1 |
Plus 5 more product codes.
Review panels
- Orthopedic (32)
- Ear, Nose and Throat (1)
Most recent Seaspine, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K231654 | NorthStar OCT System | NKG | 2023-08-03 | 58 |
| K212135 | Dry DBM- A Putty | MQV | 2021-10-04 | 88 |
| K150469 | Integra Laminoplasty System | NQW | 2015-03-23 | 28 |
| K142488 | SeaSpine Spacer System - (Hollywood, Pacifica, Redondo, Ventura) NanoMetalene, Cambria NanoMetalene , Vu aPOD-L NanoMetalene, Vu ePOD NanoMetalene | MAX | 2014-12-18 | 105 |
| K133418 | INTEGRA EXPANDABLE INTERVEREBRAL BODY FUSION DEVICE (IBD) SYSTEM | MAX | 2014-05-01 | 175 |
| K132859 | INTEGRA FACET FIXATION SYSTEM | MRW | 2013-11-18 | 67 |
| K121924 | INTEGRA INTERSPINOUS PROCESS SYSTEM | PEK | 2013-09-04 | 429 |
| K130830 | INTEGRA LAMINOPLASTY SYSTEM | NQW | 2013-05-09 | 44 |
| K122571 | MALIBU SPINAL SYSTEM WITH THE DAYTONA DEFORMITY SYSTEM | NKB | 2012-12-12 | 111 |
| K112206 | CARDIFF ANTERIOR CERVICAL PLATE SYSTEM | KWQ | 2012-01-25 | 177 |
23 earlier clearances. See the full list in Caduvo.
Recalls
11 product recalls in 2 recall events; 0 initiated in the last five years. Most recent: 2014-05-21.
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.
Device clinical trials
Seaspine, Inc. is the industry lead sponsor of 3 device studies on ClinicalTrials.gov (1 active or recruiting). Most recent:
- NCT04364295: Stronger Together Global Registry (Enrolling by invitation, started 2020-03-20)
- NCT01714804: Efficacy and Safety of Integra Accell Evo3 DBM in Instrumented Lumbar Spine Fusion (Completed, started 2012-08)
- NCT01430299: Efficacy and Safety of Accell Evo3 Demineralized Bone Matrix (DBM) in Instrumented Posterolateral Lumbar Spine Fusion (Completed, started 2011-06)
Frequently asked questions
How many FDA 510(k) clearances does Seaspine, Inc. have?
Seaspine, Inc. has 33 FDA 510(k) clearances (first 2003, latest 2023), across 15 product codes in 2 review panels.
How long does FDA take to clear Seaspine, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Seaspine, Inc.'s cleared 510(k)s is 89 days.
What devices does Seaspine, Inc. make?
Its most frequent FDA product codes are NKB (Thoracolumbosacral Pedicle Screw System, 6); MAX (Intervertebral Fusion Device With Bone Graft, Lumbar, 5); KWQ (Appliance, Fixation, Spinal Intervertebral Body, 4).
Has Seaspine, Inc. had device recalls?
openFDA lists 11 product recalls in 2 recall events by a recalling firm whose name matches Seaspine, Inc; the most recent began 2014-05-21. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 33 Seaspine, Inc. clearances with predicates and recalls
- Run predicate analysis for product code NKB, Seaspine, Inc.'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.