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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device screw, fixation, intraosseous
Regulation Description Intraosseous fixation screw or wire.
Product CodeDZL
Regulation Number 872.4880
Device Class 2


Premarket Reviews
ManufacturerDecision
BICON
  SUBSTANTIALLY EQUIVALENT 1
BIOHORIZONS IMPLANT SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 3
BIOMET
  SUBSTANTIALLY EQUIVALENT 4
BIOPLATE, INC.
  SUBSTANTIALLY EQUIVALENT 1
IMPLANT INNOVATIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
KINAMED, INC.
  SUBSTANTIALLY EQUIVALENT 1
KLS MARTIN GMBH + CO. KG
  SUBSTANTIALLY EQUIVALENT 3
MILTEX
  SUBSTANTIALLY EQUIVALENT 1
MITEK
  SUBSTANTIALLY EQUIVALENT 3
OSTEOGENICS BIOMEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
OSTEOMED
  SUBSTANTIALLY EQUIVALENT 5
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 1
SYNTHES
  SUBSTANTIALLY EQUIVALENT 13
W. LORENZ SURGICAL
  SUBSTANTIALLY EQUIVALENT 2
W.L. GORE & ASSOCIATES,INC
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
No Known Device Problem 36
Break 25
Material fragmentation 11
Implant, removal of 3
Detachment of device component 2
Difficult to remove 2
Material twisted 1
Bent 1
Device or device fragments location unknown 1
Component(s), broken 1
Difficult to insert 1
Total Device Problems 84

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 1 0 0 2 0 0 1
Class III 0 0 0 1 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Biomet 3i, LLC II Jul-06-2010
2 Biomet Microfixation, Inc. III Aug-11-2010
3 Synthes (USA) Products LLC II Apr-05-2016
4 Synthes USA HQ, Inc. II Jul-17-2013
5 Synthes USA HQ, Inc. II Mar-01-2013

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