FDA product code PLW

Acetabular Cup Orientation System

Orthopedic·Class 2·21 CFR 888.3350
US regulatory classifications
US Product Code (FDA)
PLW
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US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 888.3350
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Medical specialty
Orthopedic
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not Eligible
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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About this record

Acetabular Cup Orientation System is a medical device type in the Orthopedic specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.