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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device instrument, surgical, sonic and accessory/attachment
Regulation Description Sonic surgical instrument and accessories/attachments.
Product CodeJDX
Regulation Number 888.4580
Device Class 2


Premarket Reviews
ManufacturerDecision
DEPUY INTL., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SATELEC
  SUBSTANTIALLY EQUIVALENT 1
SRA DEVELOPMENTS, LTD.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Device operates differently than expected 2
Device sensing issue 2
Unintended movement 1
No Information 1
Break 1
Intermittent continuity 1
Unintended energization 1
Disassembly 1
Fracture 1
Mechanical issue 1
Device inoperable 1
Device displays error message 1
Total Device Problems 14

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