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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device orthopedic augmented reality
Regulation Description Stereotaxic instrument.
Definition An orthopedic augmented reality device provides visual guidance during orthopedic procedures, where the use of stereotaxic navigation is utilized. Visual guidance is displayed as “augmented reality” stereoscopic images to intraoperatively augment the user’s field of view.
Product CodeSBF
Regulation Number 882.4560
Device Class 2


Premarket Reviews
ManufacturerDecision
AUGMEDICS LTD.
  SUBSTANTIALLY EQUIVALENT 1
KICO KNEE INNOVATION COMPANY PTY LTD
  SUBSTANTIALLY EQUIVALENT 1
ONPOINT SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
SURGICAL THEATER, INC.
  SUBSTANTIALLY EQUIVALENT 1
TAIWAN MAIN ORTHOPAEDIC BIOTECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

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