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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device orthopedic computer controlled surgical system
Regulation Description Stereotaxic instrument.
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).
Product CodeOJP
Regulation Number 882.4560
Device Class 2


Premarket Reviews
ManufacturerDecision
INTEGRATED MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1

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