510(k) K082231 ยท KYJ Prosthesis, Finger, Constrained, Polymer
ASCENSION SILICONE PIP
| Applicant | Ascension Orthopedics, Inc., Austin TX, US |
| Decision | Substantially Equivalent, Jan 12, 2009 |
| Received | Aug 7, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K082231
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 4, 2019 | Integra Lifesciences Sales Llc Ascension Silicone PIP-Silicone PIP Sz 1, Model Number: SPIP5201WW - Product Usage:
The Ascension Silicone PIP implant is intended for cementless replacement of the proximal interphalangeal joint in Terminated |
KYJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.