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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device pedicle screw placement guide
Regulation Description Thoracolumbosacral pedicle screw system.
Definition A pedicle screw placement guide is intended to be used as a surgical instrument to assist in the intra-operative placement of pedicle screws that are used to anchor pedicle screw spinal systems onto the posterior elements of the spine. The device utilizes anatomic landmarks that are identifiable on pre-operative imaging scans.
Product CodePQC
Regulation Number 888.3070
Device Class 2


Premarket Reviews
ManufacturerDecision
MEDACTA INTERNATIONAL SA
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Use of Device Problem 1
Total Device Problems 1


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