510(k) K253392 ยท QLQ Manual Instruments Designed For Use With Total Disc Replacement Devices
Synergy Disc Instruments
| Applicant | Synergy Spine Solutions, Inc., Louisville CO, US |
| Decision | Substantially Equivalent, Mar 27, 2026 |
| Received | Sep 30, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253392
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.