510(k) K231593 ยท KWQ Appliance, Fixation, Spinal Intervertebral Body
Sapphire X3 Anterior Cervical Plate System
| Applicant | Spinal Elements, Inc., Carlsbad CA, US |
| Decision | Substantially Equivalent, Aug 2, 2023 |
| Received | Jun 1, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K231593
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.