510(k) K183113 ยท MQN External Mandibular Fixator And/Or Distractor
DePuy Synthes Maxillofacial Portfolio - MR Conditional
| Applicant | Synthes (USA) Products, LLC, West Chester PA, US |
| Decision | Substantially Equivalent, Mar 13, 2019 |
| Received | Nov 9, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K183113
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.