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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device handpiece, rotary bone cutting
Regulation Description Bone cutting instrument and accessories.
Product CodeKMW
Regulation Number 872.4120
Device Class 2


Premarket Reviews
ManufacturerDecision
OSTEOMED
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
No Information 17
Maintenance does not comply to manufacturers recommendations 3
Improper or incorrect procedure or method 2
Device operates differently than expected 2
Break 2
Mechanical issue 2
Overheating of device or device component 2
Failure to service 1
Inadequate instructions for healthcare professional 1
Device maintenance issue 1
Temperature issue 1
No code available 1
Total Device Problems 35

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