510(k) K060560 ยท KWD Prosthesis, Toe, Hemi-, Phalangeal
ASCENSION PYROSPHERE CMC/TMT
| Applicant | Ascension Orthopedics, Inc., Austin TX, US |
| Decision | Substantially Equivalent, May 5, 2006 |
| Received | Mar 2, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K060560
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 16, 2014 | Integra LifeSciences Corp. Ascension Orthopedics PyroSphere CMC & PyroSphere TMT, intended to replace the joint between the first metacarpal and the trapezium and 4th/5th tarsometatarsal where degenerative of post-traumatic art Terminated |
KWD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.