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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device anchor, suture, bone fixation, metallic
Regulation Description Single/multiple component metallic bone fixation appliances and accessories.
Definition This device is indicated for attaching suture into bone for suspension of the nasal valve and for attaching suture into bone at the lower orbital rim.
Product CodeNOV
Regulation Number 888.3030
Device Class 2


Premarket Reviews
ManufacturerDecision
MITEK
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Unknown (for use when the device problem is not known) 2
Device Issue 1
Premature deployment 1
Device remains implanted 1
Total Device Problems 5

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