Panels › Orthopedic › Product code OQI · Class 2
Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented
Regulation 888.3353
1510(k)s in 12 months (5 all time)
0recalls in 12 months (4 all time)
4recalls that name a 510(k)
Top companies in OQI
| Company | 510(k)s | Recalls |
|---|---|---|
| Exactech, Inc. | 1 | 3 |
| Corin USA | 1 | 0 |
| Implantcast GmbH | 1 | 0 |
| Maxx Orthopedics, Inc. | 1 | 0 |
| United Orthopedic Corporation | 1 | 0 |
| Zimmer, Inc. | 0 | 1 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 | K173583 |
| 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 | K173583 |
| Jan 18, 2024 | Exactech, Inc. AcuMatch Hip System, Catalog Number 142-32-27 Open, Classified |
OQI | K173583 |
| Oct 5, 2022 | Zimmer, Inc. G7 Acetabular System, Acetabular Shell, Item numbers Item Numbers: 010000663 (52 MM E), 010000667 (60 MM G). used in hip arthroplasty Open, Classified |
OQI | K121874 |
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