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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device cranial distraction system
Regulation Description Preformed nonalterable cranioplasty plate.
Definition A cranial distraction system is a metal device intended to establish osteodistraction and bone growth in the skull. The bone segments are attached to the plate with screws to prevent movement of the segments.
Product CodePBJ
Regulation Number 882.5330
Device Class 2


Premarket Reviews
ManufacturerDecision
KLS MARTIN GMBH + CO. KG
  SUBSTANTIALLY EQUIVALENT 1
OSTEOMED
  SUBSTANTIALLY EQUIVALENT 2

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