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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device battery-powered instruments charged through sterile barriers
Definition Battery-powered instruments intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissues (bones) and soft tissues. Accessories or attachments may include saw blades, drill chuck, pin driver, and reamer.
Product CodeSAM
Regulation Number 878.4820
Device Class 1


Premarket Reviews
ManufacturerDecision
PELETON SURGICAL
  SUBSTANTIALLY EQUIVALENT 1

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