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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device arthroscopic or orthopedic endoscopic intraoperative augmented reality video see-through display system
Definition This device consists of augmented reality software on a head-mounted display that displays arthroscopic or endoscopic video and medical imaging during orthopedic surgery. The device is intended to intraoperatively augment visualization with contextually relevant information and data, including that received from other devices.
Product CodeSIT
Regulation Number 888.1150
Device Class 2


Premarket Reviews
ManufacturerDecision
STRYKER ENDOSCOPY
  GRANTED 1

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