510(k) K092900 ยท PHX Shoulder Prosthesis, Reverse Configuration
EXACTECH EQUINOXE PLATFORM FRACTURE STEM AND REVISION PLATFORM FRACTURE STEM
| Applicant | Exactech, Inc., Gainesville FL, US |
| Decision | Substantially Equivalent, Jan 7, 2010 |
| Received | Sep 21, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K092900
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 25, 2020 | Exactech, Inc. Equinoxe Platform Fracture Stem, 6.5mm, Left - Product Usage: The Equinoxe Platform Fracture Stem is indicated for cemented use only. Terminated |
PHX | None listed |
| Sep 25, 2020 | Exactech, Inc. Equinoxe Platform Fracture Stem, 6.5mm, Right - Product Usage: The Equinoxe Platform Fracture Stem is indicated for cemented use only. Terminated |
PHX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.