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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device growing rod system
Definition Stabilization or correction of spinal deformities without the use of fusion.
Product CodePGM
Device Class Unclassified


Premarket Reviews
ManufacturerDecision
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 2
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Loose or intermittent connection 3
No Known Device Problem 3
Migration of device or device component 2
Fracture 1
Total Device Problems 9

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