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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device orthopaedic surgical planning and instrument guides
Regulation Description Single/multiple component metallic bone fixation appliances and accessories.
Definition As a surgical instrument to assist in pre-operative planning and/or guiding the marking of bone and/or guide surgical instruments for orthopedic surgical procedures.
Product CodePBF
Regulation Number 888.3030
Device Class 2


Premarket Reviews
ManufacturerDecision
KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 1
KLS MARTIN GMBH and CO. KG
  SUBSTANTIALLY EQUIVALENT 1
VIDAR SYSTEMS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Adverse Event Without Identified Device or Use Problem 1
Total Device Problems 1


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