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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device sacroiliac joint guidewire placement device
Regulation Description Smooth or threaded metallic bone fixation fastener.
Definition A sacroiliac joint guidewire placement device is intended to be used to assist in locating the sacroiliac joint and placing a guidewire in the joint as part of sacroiliac joint fusion surgeries to place implants into the sacroiliac joint.
Product CodeSCY
Regulation Number 888.3040
Device Class 2


Premarket Reviews
ManufacturerDecision
SPINEGUARD
  SUBSTANTIALLY EQUIVALENT 1

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