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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device system, facet screw spinal device
Product CodeMRW
Device Class Unclassified


Premarket Reviews
ManufacturerDecision
ALPHATEC
  SUBSTANTIALLY EQUIVALENT 2
CUSTOM SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 1
DEPUY INTL., LTD.
  SUBSTANTIALLY EQUIVALENT 2
EXACTECH, INC.
  SUBSTANTIALLY EQUIVALENT 1
GLOBUS
  SUBSTANTIALLY EQUIVALENT 2
INTERVENTIONAL SPINE, INC.
  SE - WITH LIMITATIONS 1
  SUBSTANTIALLY EQUIVALENT 1
LANX
  SUBSTANTIALLY EQUIVALENT 1
LIFE SPINE
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 4
NUVASIVE
  SUBSTANTIALLY EQUIVALENT 4
OSTEOMED
  SUBSTANTIALLY EQUIVALENT 1
SOFAMOR DANEK
  SUBSTANTIALLY EQUIVALENT 1
SPINE WAVE, INC.
  SUBSTANTIALLY EQUIVALENT 1
SPINEFRONTIER, INC.
  SUBSTANTIALLY EQUIVALENT 1
SPINEOLOGY INC.
  SUBSTANTIALLY EQUIVALENT 1
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 1
TRANS1
  SUBSTANTIALLY EQUIVALENT 2
TRIAGE MEDICAL INC
  SUBSTANTIALLY EQUIVALENT 1
X-SPINE SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Not Applicable 2
Device handling issue 1
Misassembled 1
Implant, repositioning of 1
Malposition of device 1
Device or device component damaged by another device 1
Total Device Problems 7

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

Recalls
Manufacturer Recall Class Date Posted
1 Interventional Spine Inc II Aug-18-2011
2 Osteomed, Lp II Oct-04-2011

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