510(k) K182536 ยท PHX Shoulder Prosthesis, Reverse Configuration
Exactech Equinoxe Small Reverse Shoulder Glenospheres , Exactech Equinoxe Reverse Shoulder Humeral Liners , Exactech Equinoxe Small Reverse Shoulder Glenoid Plates , Exactech Equinoxe Reverse Shoulder Locking Cap
| Applicant | Exactech, Inc., Gainesville FL, US |
| Decision | Substantially Equivalent, Oct 12, 2018 |
| Received | Sep 14, 2018 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K182536
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 29, 2024 | Exactech, Inc. Exactech Equinoxe Humeral Liner: Item Numbers: a) 320-40-00, b) 320-40-03; Shoulder Arthroplasty Open, Classified |
PHX | None listed |
| Mar 29, 2024 | Exactech, Inc. Exactech Equinoxe Constrained Humeral Liner: Item Numbers: a) 320-40-10, b) 320-40-13, Shoulder Arthroplasty Open, Classified |
PHX | None listed |
| Jan 18, 2024 | Exactech, Inc. Exactech Equinoxe Reverse Shoulder System, Catalog Numbers:
a) 320-36-00,
b) 320-36-03,
c) 320-36-04,
d) 320-36-10,
e) 320-36-13,
f) 320-38-00,
g) 320-38-13,
h) 320-40-00,
i) 320-40-10,
j) Open, Classified |
KWT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.