510(k) K121589 ยท JEY Plate, Bone
BIOMET MICROFIXATION FACIAL PLATING SYSTEM
| Applicant | Biomet Microfixation, Jacksonville FL, US |
| Decision | Substantially Equivalent, Sep 21, 2012 |
| Received | May 31, 2012 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K121589
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 10, 2017 | Zimmer Biomet, Inc. 1.5mm System, Cranio-maxillofacial Bone Screws 1.5 x 4mm HT SD X-DR Screw, Bone Screw Terminated |
HWC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.