510(k) K170818 ยท PBJ Cranial Distraction System
Craniomaxillofacial Distraction System (CMFD)
| Applicant | Synthes USA Products, LLC, West Chester PA, US |
| Decision | Substantially Equivalent, Dec 7, 2017 |
| Received | Mar 20, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K170818
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.