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Orthopedic Computer Controlled Surgical System

FDA product code OJP · 1 cleared devices

Class 2 Neurology
Regulation
21 CFR 882.4560
Review panel
OR
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2008-08-06 – 2008-08-06

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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