510(k) K162726 · PHX Shoulder Prosthesis, Reverse Configuration
Exactech® Equinoxe® Preserve Stem
| Applicant | Exactech, Inc., Gainesville FL, US |
| Decision | Substantially Equivalent, Feb 1, 2017 |
| Received | Sep 29, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K162726
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 5, 2018 | Exactech, Inc. Equinoxe Preserve Humeral Stem, 8mm
Product Usage:
The Equinoxe Preserve Stems are indicated for use in skeletally mature individuals with degenerative diseases of the glenohumeral joint where anatom Terminated |
PHX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.