510(k) K231807 · PEK Spinous Process Plate
primaLOK SP Interspinous Fusion System
| Applicant | Wenzel Spine, Inc., Austin TX, US |
| Decision | Substantially Equivalent, Aug 15, 2023 |
| Received | Jun 20, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K231807
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.