510(k) K101909 ยท PHX Shoulder Prosthesis, Reverse Configuration
EXACTECH EQUINOXE, PLATFORM FRACTURE STEM
| Applicant | Exactech, Inc., Gainesville FL, US |
| Decision | Substantially Equivalent, Aug 2, 2010 |
| Received | Jul 8, 2010 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K101909
| 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 |
| Dec 3, 2019 | Exactech, Inc. Exactech equinoxe PLATFORM FRACTURE, HUMERAL STEM, CEMENTED, Right, 6.5mm, REF 304-22-07 - Product Usage: The Equinoxe Shoulder System is indicated for use and in skeletally mature individuals with de Terminated |
PHX | None listed |
| Dec 3, 2019 | Exactech, Inc. Exactech equinoxe PLATFORM FRACTURE, HUMERAL STEM, CEMENTED, Right, 10.5mm, REF 304-22-11 - Product Usage: The Equinoxe Shoulder System is indicated for use and in skeletally mature individuals with d Terminated |
PHX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.