Acetabular Cup Orientation System
FDA product code PLW · Class II (moderate risk) · 21 CFR 888.3350 · Orthopedic
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.
1510(k) clearances
0PMA approvals
0recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K150780 | Acetabular Cup Orientation SystemPLW · Traditional | Materialise NV | 10/27/2015SE |