PLW
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Acetabular Cup Orientation System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3350
- Medical specialty
- Orthopedic
- FDA definition
- The acetabular cup orientation system is intended to be used as a surgical instrument to assist in the intra-operative orientation of acetabular cup components used with total hip arthroplasty. The device utilizes anatomic landmarks of the pelvis that are clearly identifiable on pre-operative imaging scans.
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| Record | Firm | Date |
|---|---|---|
| Acetabular Cup Orientation System (K150780) | Materialise NV | 2015-10-27 |
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