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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device intraoperative orthopedic joint assessment aid
Definition Measurement and interpretation of orthopedic joint information.
Product CodeONN
Regulation Number 882.4560
Device Class 2


Premarket Reviews
ManufacturerDecision
ORTHOSENSOR, INC.
  SUBSTANTIALLY EQUIVALENT 3
THESE THREE MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1

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