510(k) K043100 ยท MBF Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented
BIO-MODULAR SHOULDER SYSTEM WITH HYDROXYAPATITE (HA) COATED GLENOID COMPONENTS
| Applicant | Biomet, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, Feb 17, 2005 |
| Received | Nov 9, 2004 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K043100
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 21, 2019 | Zimmer Biomet, Inc. BIOMOD PORCOAT HA GLENTRAY; Custom Shoulder Products
Item Nos. PM0000097
PM555140
PM555147
PM555319
PM555418
113867
113865
113863
Product Usage: Total Shoulder Replacement Terminated |
MBF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.