510(k) K061451 ยท KYI Prosthesis, Wrist, Carpal Trapezium
ASCENSION, MODELS CMC-400,13,CMC-400-20,CMC-400-30,CMC-400-40
| Applicant | Ascension Orthopedics, Inc., Austin TX, US |
| Decision | Substantially Equivalent, Aug 11, 2006 |
| Received | May 25, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K061451
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 21, 2013 | Integra LifeSciences Corp. CMC Saddle
Product Usage: The Ascension CMC is intended to resurface the proximal end of the first metacarpal in cases of rheumatoid arthritis, traumatic arthritis, osteo-arthritis, or post-fracture Terminated |
KYI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.