510(k) K060138 ยท MQN External Mandibular Fixator And/Or Distractor
SYNTHES (USA) CRANIOMAXILLOFACIAL DISTRACTION SYSTEM
| Applicant | Synthes (Usa), West Chester PA, US |
| Decision | Substantially Equivalent, Jun 2, 2006 |
| Received | Jan 19, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K060138
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 20, 2014 | Synthes, Inc. DePuy Synthes Craniomaxillofacial Distraction System (AB Distractor Bodies and BC Distractor Bodies) Terminated |
MQN | None listed |
| Jul 12, 2013 | Synthes USA HQ, Inc. Synthes CMF Distraction System
The product is intended for use as a bone stabilizer and lengthening (and/or transport) device for correction of congenital deficiencies or post-traumatic defects of th Terminated |
MQN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.