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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device sacroiliac joint fixation
Regulation Description Smooth or threaded metallic bone fixation fastener.
Definition sacroiliac joint fusion
Product CodeOUR
Regulation Number 888.3040
Device Class 2


Premarket Reviews
ManufacturerDecision
DEPUY INTL., LTD.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 2
SPINEFRONTIER, INC.
  SUBSTANTIALLY EQUIVALENT 1
X-SPINE SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Malposition of device 134
No Known Device Problem 125
Failure to osseointegrate 12
Device handling issue 7
Break 5
Difficult to remove 4
Device or device component damaged by another device 4
Use of Device Issue 2
Fracture 1
Difficult to insert 1
Difficult to advance 1
Total Device Problems 296

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