510(k) K141990 ยท PHX Shoulder Prosthesis, Reverse Configuration
ENCORE HUMERAL SHOULDER STEM
| Applicant | Encore Medical L.P., Austin TX, US |
| Decision | Substantially Equivalent, Nov 7, 2014 |
| Received | Jul 22, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K141990
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 5, 2018 | Encore Medical, Lp AltiVate Reverse INSTRUMENTATION, HUMERAL SOCKET SHELL TRIAL, STANDARD, REF 804-06-152, Qty: 01, Encore Medical, LP Orthopedic surgical instrument.
Product Usage:
The humeral socket shell trial is u Terminated |
PHX | None listed |
| Jan 9, 2016 | Encore Medical, Lp AltiVate Reverse Humeral Broach, Size 10 Catalog number 804-06-040, Size 14 Catalog number 804-06-044, and Size 16 Catalog number 804-06-046. Orthopedic surgical instrument for use with Encore Should Terminated |
PHX | None listed |
| Oct 16, 2015 | Encore Medical, Lp AltiVate Humeral Socket Shell Trial, Part Number 804-06-052
The glenoid baseplate is intended for cementless application with addition of screws for fixation. The humeral stem is intended for cemente Terminated |
PHX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.