510(k) K130840 ยท JEY Plate, Bone
SMARTBUILDER SYSTEM (SB1)
| Applicant | Osstem Implant Co., Ltd., Fariless Hills PA, US |
| Decision | Substantially Equivalent, Sep 18, 2013 |
| Received | Mar 27, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K130840
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.