510(k) K100448 ยท KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
ASCENSION MODULAR TOTAL SHOULDER SYSTEM
| Applicant | Ascension Orthopedics, Inc., Austin TX, US |
| Decision | Substantially Equivalent, Aug 30, 2010 |
| Received | Feb 17, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K100448
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 8, 2014 | Integra LifeSciences Corp. Integra Titan Reverse Shoulder System right and left head cutting templates, 142.5 degrees.
The Reverse Shoulder System Cutting Template, 142.5 degrees is an accessory for use with the Integra Titan Terminated |
KWS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.