510(k) K173583 · OQI Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented
Exactech® Novation® and AcuMatch® E-HXL Acetabular Liners
| Applicant | Exactech, Inc., Gainesville FL, US |
| Decision | Substantially Equivalent, Mar 12, 2018 |
| Received | Nov 20, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K173583
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 12, 2025 | Exactech, Inc. AcuMatch XLE
Item Number / Product Description:
140-28-27 AM EHXL 0 LNR G 28MM
140-32-27 AM EHXL 0 LNR G 32MM
140-32-28 AM EHXL 0 LNR H 32MM
140-28-29 AM EHXL 0 LNR J 28MM
140-32-29 AM EHXL 0 LNR J 32 Open, Classified |
OQI | None listed |
| Feb 12, 2025 | Exactech, Inc. Novation 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 EH Open, Classified |
OQI | None listed |
| Jan 18, 2024 | Exactech, Inc. AcuMatch Hip System, Catalog Number 142-32-27 Open, Classified |
OQI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.