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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 remains implanted 1
Device Issue 1
Premature deployment 1
Total Device Problems 5

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 0 0 0 0
Class II 0 0 0 0 0 0 0 0 0 1 0
Class III 0 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Integra LifeSciences Corp. II Sep-07-2016

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