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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device cranial surgical planning and instrument guides
Regulation Description Powered simple cranial drills, burrs, trephines, and their accessories.
Definition Software and hardware for surgical planning to create patient-specific anatomical models, surgical templates, and guides for use in the marking or cutting of cranial bone for neurosurgical procedures.
Product CodePPT
Regulation Number 882.4310
Device Class 2


Premarket Reviews
ManufacturerDecision
MATERIALISE NV
  SUBSTANTIALLY EQUIVALENT 1

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