510(k) K253118 · QLR Manual Instruments Designed For Use With Non-Fusion Spinous Process Spacer Devices
Companion Spine DIAM Instrumentation
| Applicant | Companion Spine France, Mérignac, FR |
| Decision | Substantially Equivalent, Dec 16, 2025 |
| Received | Sep 24, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253118
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.