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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device pedicle screw spinal system, adolescent idiopathic scoliosis
Regulation Description Pedicle screw spinal system.
Definition Intended to stabilize the thoracolumbar spine as an adjunct to fusion using allograft and/or autograft to treat adolescent idiopathic scoliosis.
Product CodeOSH
Regulation Number 888.3070
Device Class 2


Premarket Reviews
ManufacturerDecision
GLOBUS
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Material integrity issue 3
No Information 1
Break 1
Implant breakage or physical damage 1
Total Device Problems 6

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