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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device defect measurement tool
Definition Manual surgical instrument for appropriate patient select for orthopedic implant is a device used to measure an anatomical feature(s) to determine appropriate patient selection for an orthopedic implant. The characteristics of the instrument are defined by the specifications set for use of the orthopedic implant in terms of geometry, surgical technique, and use of the device.
Product CodeQHG
Regulation Number 888.4510
Device Class 2


Premarket Reviews
ManufacturerDecision
INTRINSIC THERAPEUTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1

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