510(k) K062494 ยท HRS Plate, Fixation, Bone
EBI OPTILOCK UPPER EXTREMITY PLATING SYSTEM
| Applicant | Ebi, L.P., Parsippany NJ, US |
| Decision | Substantially Equivalent, Oct 19, 2006 |
| Received | Aug 25, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K062494
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 19, 2012 | Biomet, Inc. Optilock, Locking Screw 3.5 mm x 28 mm, non sterile, REF 37728, Biomet Trauma Parsippany, NJ 97054.
Cortical Locking Screw for securing a Proximal Humeral Plate to the bone in the Optilock system. Terminated |
HRS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.