510(k) K160465 ยท PEK Spinous Process Plate
Spinal Elements' Spinous Process Plate System
| Applicant | Spinal Elements, Inc., Carlsbad CA, US |
| Decision | Substantially Equivalent, Jul 28, 2016 |
| Received | Feb 19, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K160465
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.