510(k) K120951 ยท JEY Plate, Bone
SMARTBUILDER SYSTEM
| Applicant | Osstem Implant Co., Ltd., Fariless Hills PA, US |
| Decision | Substantially Equivalent, Oct 3, 2012 |
| Received | Mar 30, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K120951
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.