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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device cement, bone, pre-formed, modular, polymeric, vertebroplasty
Regulation Description Polymethylmethacrylate (PMMA) bone cement.
Definition Reduction of vertebral body fractures in conjunction with PMMA bone cement cleared for vertebroplasty and restoration of vertebral body height.
Product CodeOBL
Regulation Number 888.3027
Device Class 2


Premarket Reviews
ManufacturerDecision
SPINE WAVE, INC.
  SUBSTANTIALLY EQUIVALENT 1

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