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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device orthosis, limb brace
Regulation Description Limb orthosis.
Product CodeIQI
Regulation Number 890.3475
Device Class 1


Premarket Reviews
ManufacturerDecision
3M COMPANY
  SUBSTANTIALLY EQUIVALENT 1
AIRCAST, INC.
  SUBSTANTIALLY EQUIVALENT 2
BIOMET
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
OTTO BOCK HEALTHCARE, GMBH
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
No Known Device Problem 16
No Information 2
Device operates differently than expected 2
Unknown (for use when the device problem is not known) 2
Device Issue 2
Failure to obtain samples 1
Component(s), broken 1
Material rupture 1
Use of Device Issue 1
Total Device Problems 28

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 1 1 1
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Breg Inc II Apr-10-2014
2 Ossur H / F II Mar-31-2016
3 United Surgical Associates II May-23-2015

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