PLW — Acetabular Cup Orientation System Class II
FDA product code PLW covers "Acetabular Cup Orientation System", a Class II medical device regulated under 21 CFR 888.3350. Submissions are reviewed by the Orthopedic panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- PLW
- Device Class
- Class II
- Regulation Number
- 888.3350
- Submission Type
- Review Panel
- OR
- Medical Specialty
- Orthopedic
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K150780 | materialise | Acetabular Cup Orientation System | October 27, 2015 |