510(k) K041451 ยท KYI Prosthesis, Wrist, Carpal Trapezium
ASCENSION PYROHEMISPHERE, MODELS PHS-440-10, PHS-440-20, PHS-440-30, PHS-440-40, PHS-440-50
| Applicant | Ascension Orthopedics, Inc., Austin TX, US |
| Decision | Substantially Equivalent, Aug 25, 2004 |
| Received | Jun 1, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K041451
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 22, 2010 | Ascension Orthopedics, Inc The Ascension PyroHemiSphere (aka NuGrip), Model #30-L NUG-443-30L, Catalog #NUG-443-30L, Lot #10-0731, is a single-use uncemented, one-component prosthesis for the basal thumb joint.
The NuGrip is Terminated |
KYI | None listed |
| Nov 22, 2010 | Ascension Orthopedics, Inc The Ascension PyroHemiSphere (aka NuGrip), Model #40-M NUG-443-40M, Catalog #NUG-443-40M, Lot #10-0469, is a single-use uncemented, one-component prosthesis for the basal thumb joint.
The NuGrip is Terminated |
KYI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.