510(k) K201029 · KWQ Appliance, Fixation, Spinal Intervertebral Body
Sapphire® Spinal System, Sapphire X Anterior Cervical Plate Spinal System
| Applicant | Spinal Elements, Inc., Carlsbad CA, US |
| Decision | Substantially Equivalent, Jun 17, 2020 |
| Received | Apr 20, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K201029
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.