510(k) K081016 ยท PHX Shoulder Prosthesis, Reverse Configuration
SMITH & NEPHEW, INC., PROMOS REVERSE SHOULDER SYSTEM
| Applicant | Smith & Nephew, Inc., Memphis TN, US |
| Decision | Substantially Equivalent, Sep 5, 2008 |
| Received | Apr 9, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K081016
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 3, 2009 | Smith & Nephew Inc PROMOS Releasing Clamp (3 parts), REF 420 189, S&N 75006600, Rx only, QTY(1), non-sterile
Instrument for prosthesis, shoulder, semi-constrained, metal/polymer cementer Terminated |
KWS | None listed |
| Feb 3, 2009 | Smith & Nephew Inc PROMOS Reverse, Glenosphere Loosening Adapter, REF 24 000 047, S&N 75005271, Rx only, QTY(1), non-sterile
Instrument for prosthesis, shoulder, semi-constrained, metal/polymer cementer Terminated |
KWS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.