Spine Wave, Inc.: FDA filings under this applicant name
FDA lists 59 510(k) clearances under the applicant name “Spine Wave, Inc.” (first 2004, latest 2026), across 14 product codes in 1 review panel. Median 510(k) review time under this name: 83 days. Since 2017 the median was 76 days, against 91 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 3 | 77 |
| 2013 | 5 | 49 |
| 2014 | 3 | 95 |
| 2015 | 7 | 29 |
| 2016 | 4 | 124 |
| 2017 | 6 | 123 |
| 2018 | 3 | 59 |
| 2019 | 2 | 54 |
| 2020 | 1 | 69 |
| 2021 | 0 | — |
| 2022 | 1 | 25 |
| 2023 | 1 | 84 |
| 2024 | 1 | 55 |
| 2025 | 3 | 141 |
| 2026 | 2 | 94 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Spine Wave, Inc. took a median 76 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 91 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 14 | 14 |
| MNI | Orthosis, Spinal Pedicle Fixation | 11 | 11 |
| MQP | Spinal Vertebral Body Replacement Device | 10 | 10 |
| NKB | Thoracolumbosacral Pedicle Screw System | 7 | 7 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | 3 | 3 |
| NKG | Posterior Cervical Screw System | 3 | 3 |
| OLO | Orthopedic Stereotaxic Instrument | 3 | 3 |
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | 2 | 2 |
| HRS | Plate, Fixation, Bone | 1 | 1 |
| MRW | System, Facet Screw Spinal Device | 1 | 1 |
Plus 4 more product codes.
Review panels
- Orthopedic (59)
Most recent Spine Wave, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K260286 | Dynamo Spinal Cement; Salvo® Spine System | PML | 2026-06-15 | 137 |
| K261159 | Exceed® Biplanar Expandable Interbody System | MAX | 2026-05-29 | 51 |
| K243816 | Testa TP Pivoting Spacer System | MAX | 2025-06-27 | 197 |
| K251131 | Annex® 2 Adjacent Level System | NKB | 2025-06-06 | 56 |
| K243514 | Salvo® Robotic Navigation Instruments | OLO | 2025-04-03 | 141 |
| K240685 | Salvo® Spine System | NKB | 2024-05-06 | 55 |
| K231275 | Exceed Biplanar Expandable Interbody System | MAX | 2023-07-25 | 84 |
| K222362 | Salvo® Spine System | NKB | 2022-08-29 | 25 |
| K202476 | Salvo® Spine System | NKB | 2020-11-05 | 69 |
| K192526 | Spine Wave Navigated Instruments | OLO | 2019-10-10 | 27 |
49 earlier clearances. See the full list in Caduvo.
Recalls
3 product recalls in 3 recall events; 0 initiated in the last five years. Most recent: 2015-05-04.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Spine Wave, Inc. is the lead sponsor of 1 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT02108249: Annex™ Adjacent Level System for Treatment of Adjacent Level Disease (Completed, started 2014-04)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Spine Vision, Inc. (12 510(k)s)
- Spine Smith Partners L.P. (9 510(k)s)
- Spine View, Inc. (9 510(k)s)
- Spine Next America (5 510(k)s)
- Spine Next SA (3 510(k)s)
- Spine Smith Holdings, LLC (3 510(k)s)
- Spine Innovation, LLC (2 510(k)s)
- Spine Works (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Spine Wave, Inc.?
FDA lists 59 510(k) clearances under the applicant name “Spine Wave, Inc.” (first 2004, latest 2026), across 14 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Spine Wave, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Spine Wave, Inc. is 83 days. Since 2017: 76 days, versus 91 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Spine Wave, Inc.?
The most frequent FDA product codes under this applicant name are MAX (Intervertebral Fusion Device With Bone Graft, Lumbar, 14); MNI (Orthosis, Spinal Pedicle Fixation, 11); MQP (Spinal Vertebral Body Replacement Device, 10).
Next steps
- See all 59 Spine Wave, Inc. clearances with predicates and recalls
- Run predicate analysis for product code MAX, Spine Wave, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.