510(k) K182502 ยท LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Alteon Acetabular Cup System
| Applicant | Exactech, Inc., Gainesville FL, US |
| Decision | Substantially Equivalent, Mar 13, 2019 |
| Received | Sep 12, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K182502
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 12, 2025 | Exactech, Inc. Alteon XLE
Item Number / Product Description:
140-22-70 NV EHXL NTL LNR G00 22MM
140-28-50 NV EHXLNTRL LNR G0 28MM
140-28-51 NV EHXLNTRL LNR G1 28MM
140-28-52 NV EHXL NTRL LNR G228MM
140-32-51 NV EHX Open, Classified |
LPH | None listed |
| Jan 18, 2024 | Exactech, Inc. Exactech Alteon Hip XLE Liner, Catalog Numbers:
a) 01-030-40-0636,
b) 01-030-40-0640,
c) 01-030-42-0536 Open, Classified |
LPH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.