510(k) K030710 ยท KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
BIO-MODULAR SHOULDER SYSTEM
| Applicant | Biomet, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, Jun 4, 2003 |
| Received | Mar 6, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K030710
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 5, 2012 | Biomet, Inc. Bio-Modular Humeral Head 48mm x 24mm Ti 6AI4V/Ion Implanted (Orthopedic Implant)
Product Usage:
The OSS Knee Reamer Sleeves are primarily used to guide the bullet tip of cylindrical reamers during th Terminated |
KWT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.