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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device orthosis, cervical
Regulation Description Truncal orthosis.
Product CodeIQK
Regulation Number 890.3490
Device Class 1


Premarket Reviews
ManufacturerDecision
ABCO DEALERS, INC.
  SUBSTANTIALLY EQUIVALENT 1
BATTLE CREEK MANUFACTURERS, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Fracture 6
Break 3
No Known Device Problem 1
Total Device Problems 10

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

Recalls
Manufacturer Recall Class Date Posted
1 Ossur H / F II Mar-31-2016

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