510(k) K050378 ยท MQN External Mandibular Fixator And/Or Distractor
SYNTHES MANDIBLE EXTERNAL FIXATOR
| Applicant | Synthes (Usa), Paoli PA, US |
| Decision | Substantially Equivalent, Mar 15, 2005 |
| Received | Feb 15, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K050378
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 23, 2015 | Synthes, Inc. The Synthes Mandible External Fixator; all lots of part nos.:
04.305.003
04.305.004
04.305.005
04.305.010
04.305.011
04.305.012
03.305.006
04.305.100
04.305.101
04.305.102
04.305.103
04.305.128
04.3 Terminated |
MQN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.