510(k) K103404 ยท KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
ANA0TOMICAL SHOULDER TM COMBINED SYSTEM
| Applicant | Zimmer GmbH, Warsaw IN, US |
| Decision | Substantially Equivalent, Mar 15, 2011 |
| Received | Nov 19, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K103404
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 27, 2012 | Zimmer, Inc. Bigliani/Flatow The Complete Shoulder Solution Trabecular Metal Glenoid Instrument Drill with Stop, 6 mm; the products are medical instruments intended for use when performing surgery of the shoulder. Terminated |
KWT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.