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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device sacroiliac screw placement guide
Definition A sacroiliac screw placement guide is intended to be used as a surgical instrument to assist in the intra-operative placement of sacroiliac screws across the sacroiliac joint. The device utilizes anatomical landmarks that are identifiable on pre-operative imaging scans.
Product CodeQSR
Regulation Number 888.3040
Device Class 2


Premarket Reviews
ManufacturerDecision
MEDACTA INTERNATIONAL S.A.
  SUBSTANTIALLY EQUIVALENT 1

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