Synergy Spine Solutions, Inc.: FDA filings under this applicant name
FDA lists 1 510(k) clearance under the applicant name “Synergy Spine Solutions, Inc.” (first 2026, latest 2026), plus 1 PMA decision, across 2 product codes in 1 review panel. Median 510(k) review time under this name: 178 days. 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 |
|---|---|---|
| 2026 | 1 | 178 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Synergy Spine Solutions, Inc. took a median 178 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 59 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MJO | Prosthesis, Intervertebral Disc | 1 | 0 |
| QLQ | Manual Instruments Designed For Use With Total Disc Replacement Devices | 1 | 1 |
Review panels
- Orthopedic (2)
Most recent Synergy Spine Solutions, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K253392 | Synergy Disc Instruments | QLQ | 2026-03-27 | 178 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P250028 | PMA | Synergy Disc | 2026-02-26 |
Recalls
openFDA lists no recalls under a recalling firm named Synergy Spine Solutions, Inc..
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 Synergy Spine Solutions, Inc. is the lead sponsor of 5 device studies on ClinicalTrials.gov (5 active or recruiting). Most recent:
- NCT06383962: Post-Market Data Collection to Evaluate the Performance of the Synergy Disc® (Recruiting, started 2025-03-17)
- NCT06383949: Real World Data Collection on the Synergy Disc (Recruiting, started 2024-08-06)
- NCT05740176: The Synergy Disc for the Treatment of 2 Level Cervical Degenerative Disc Disease Compared With Cervical Fusion Surgery (Active not recruiting, started 2023-06-01)
- NCT05305430: Real World Data Collection on the Synergy Cervical Disc (Recruiting, started 2022-05-01)
- NCT04469231: The Synergy Disc To Anterior Cervical Discectomy and Fusion (Active not recruiting, started 2020-10-30)
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.
- Synergy Biomedical (5 510(k)s)
- Synergy Orthopaedics Intl., Inc. (2 510(k)s)
- Synergy Surgical Technologies, LLC (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Synergy Spine Solutions, Inc.?
FDA lists 1 510(k) clearance under the applicant name “Synergy Spine Solutions, Inc.” (first 2026, latest 2026), plus 1 PMA decision, across 2 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 Synergy Spine Solutions, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Synergy Spine Solutions, Inc. is 178 days.
Which FDA product codes appear under Synergy Spine Solutions, Inc.?
The most frequent FDA product codes under this applicant name are MJO (Prosthesis, Intervertebral Disc, 1); QLQ (Manual Instruments Designed For Use With Total Disc Replacement Devices, 1).
Next steps
- See all 1 Synergy Spine Solutions, Inc. clearances with predicates and recalls
- Run predicate analysis for product code MJO, Synergy Spine Solutions, 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.