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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
Regulation Description Thoracolumbosacral pedicle screw system.
Definition Stabilization or correction of spinal deformities without the use of fusion.
Product CodePGM
Regulation Number 888.3070
Device Class 2


Premarket Reviews
ManufacturerDecision
GLOBUS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
ORTHOPEDIATRICS CORP.
  SUBSTANTIALLY EQUIVALENT 1
SEASPINE ORTHOPEDICS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

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