510(k) K163315 ยท PBJ Cranial Distraction System
Internal Distraction - Sterile
| Applicant | KLS Martin L.P., Jacksonville FL, US |
| Decision | Substantially Equivalent, May 5, 2017 |
| Received | Nov 23, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K163315
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.