510(k) K113309 ยท KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
EXACTECH EQUINOXE CAGE GLENOIDS
| Applicant | Exactech, Inc., Gainesville FL, US |
| Decision | Substantially Equivalent, Dec 8, 2011 |
| Received | Nov 8, 2011 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K113309
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 29, 2024 | Exactech, Inc. Exactech Equinoxe CAGE GLENOID, CEMENTED, alpha curvature, Mates with:
a) 38, 41, 44 head, Small, Item Number 314-13-02,
b) 38, 41, 44 head, Medium, Item Number 314-13-03,
c) 38, 41, 44 head, Larg Open, Classified |
KWS | None listed |
| Mar 29, 2024 | Exactech, Inc. Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with:
a) 47, 50, 53 head, Medium, Item Number 314-13-13,
b) 47, 50, 53 head, Large, Item Number 314-13-14,
c) 47, 50, 53 head, Extra Open, Classified |
KWS | None listed |
| Mar 29, 2024 | Exactech, Inc. Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Left, Mates with:
a) 38, 41, 44, 47 head, Small, Item Number 314-13-22,
b) 41, 44, 47, 50, head, Medium, Item Number 314-13-23,
c) 44, 4 Open, Classified |
KWS | None listed |
| Mar 29, 2024 | Exactech, Inc. Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Right, Mates with:
a) 38, 41, 44, 47 head, Small, Item Number 314-13-32,
b) 41, 44, 47, 50, head, Medium, Item Number 314-13-33,
c) 44, Open, Classified |
KWS | None listed |
| Oct 6, 2020 | Exactech, Inc. Catalog 314-13-23, Equinoxe Cage Glenoid, Posterior Augment, Left, Medium Terminated |
KWS | None listed |
| Oct 6, 2020 | Exactech, Inc. Catalog 314-13-33, Equinoxe Cage Glenoid, Posterior Augment, Right, Medium Terminated |
KWS | None listed |
| Jan 18, 2018 | Exactech, Inc. Equinoxe Cage, Glenoid, Alpha, Small
Product Usage:
The Equinoxe Shoulder System is indicated for use in skeletally mature individuals with degenerative diseases or fractures of the glenohumeral join Terminated |
KWS | None listed |
| Jan 18, 2018 | Exactech, Inc. Equinoxe Cage, Glenoid, Alpha, Medium
Product Usage:
The Equinoxe Shoulder System is indicated for use in skeletally mature individuals with degenerative diseases or fractures of the glenohumeral joi Terminated |
KWS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.