FDA product code OJP

Orthopedic Computer Controlled Surgical System

Neurology·Class 2·21 CFR 882.4560
US regulatory classifications
US Product Code (FDA)
OJP
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US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 882.4560
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Medical specialty
Neurology
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not Eligible
Definition

Pre-operative planning and intra-operative execution of surgical movements with robotically controlled end effectors under user supervision. Alternative to manual planning and broaching/reaming techniques for femoral canal preparation in primary total hip arthroplasty (THA).

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About this record

Orthopedic Computer Controlled Surgical System is a medical device type in the Neurology 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.