510(k) K060694 ยท KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
MODULAR HYBRID GLENOID
| Applicant | Biomet Manufacturing Corp, Warsaw IN, US |
| Decision | Substantially Equivalent, Dec 11, 2006 |
| Received | Mar 15, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K060694
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 26, 2017 | Zimmer Biomet, Inc. Modular Hybrid Glenoid Base Large for the Comprehensive Shoulder System, The product is placed into an AlOx coated PET pouch and vacuum sealed with an Argon flush. The vacuum sealed product is then pl Terminated |
KWS | None listed |
| Mar 27, 2017 | Zimmer Biomet, Inc. various polyethylene implants
Extremities, Shoulders and Elbows
BioModular Shoulder System; Comprehensive Shoulder System; Comprehensive Reverse Shoulder System
Product Usage:
Shoulder Replacement E Terminated |
KWS | None listed |
| Jan 9, 2013 | Biomet, Inc. PT113950 PT HYBRID Glenoid Post
Regenerex porous titanium construct
Sterile R
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Terminated |
KWS | None listed |
| Sep 16, 2008 | Biomet, Inc. Biomet Hybrid Glenoid Boss Cutter; item 406150. - Surgical instrument used to prepare the natural shoulder glenoid surface for implanting a Hybrid Glenoid component. This instrument is intended to fu Terminated |
KWT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.