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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device intra-articular orthopedic stereotaxic navigation instrument
Definition An intra-articular orthopedic stereotaxic navigation instrument is a device consisting of a rigid frame of reference with a calibrated guide mechanism and fiducial markers temporarily affixed to anatomical structures within the intraarticular space. The markers are continuously tracked for precisely positioning instruments or other devices.
Product CodeSIQ
Regulation Number 888.4561
Device Class 2


Premarket Reviews
ManufacturerDecision
SMITH & NEPHEW, INC.
  GRANTED 1

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