510(k) K113650 ยท OAT Implant, Endosseous, Orthodontic
ORTHOFIX SCREW
| Applicant | Bonafix Surgical and Dental Implants, LLC, 118 W Prive Cr. FL, US |
| Decision | Substantially Equivalent, Oct 3, 2012 |
| Received | Dec 12, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K113650
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.