510(k) K962082 ยท KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
OSTEONICS ALL POLYETHYLENE GLENOID SHOULDER COMPONENT
| Applicant | Osteonics Corp., Allendale NJ, US |
| Decision | Substantially Equivalent, Aug 13, 1996 |
| Received | May 29, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K962082
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 16, 2026 | Howmedica Osteonics Corp. DURACON XL ANGLED TIB INS 11/14MM
C-M064-1-300
SELF-PRESSURIZING GLENOID SIZE 8
C-M062-6-800
C-M062-7-500
C-M063-2-600
SELF-PRESSURIZING GLENOID SIZE 9
C-M063-5-000
SHOULDER - GLENOID # Open, Classified |
KWS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.