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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device intraoperative orthopedic strain sensor
Definition A strain sensor device is an adjunct tool intended to measure strain on an orthopedic implant in the intraoperative setting only. The device is not intended to provide diagnostic information or influence clinical decision-making.
Product CodeQFP
Regulation Number 888.3090
Device Class 2


Premarket Reviews
ManufacturerDecision
INTELLIROD SPINE, INC.
  GRANTED 1

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