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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device intervertebral fusion device with integrated fixation, lumbar
Regulation Description Intervertebral body fusion device.
Definition Intended to stabilize lumbar spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft with or without supplemental fixation.
Product CodeOVD
Regulation Number 888.3080
Device Class 2


Premarket Reviews
ManufacturerDecision
AESCULAP
  SUBSTANTIALLY EQUIVALENT 2
ALPHATEC
  SUBSTANTIALLY EQUIVALENT 2
BIOMET
  SUBSTANTIALLY EQUIVALENT 4
BLACKSTONE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
CUSTOM SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 1
GLOBUS
  SUBSTANTIALLY EQUIVALENT 8
INNOVASIS, INC.
  SUBSTANTIALLY EQUIVALENT 1
LANX
  SUBSTANTIALLY EQUIVALENT 3
LIFE SPINE
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 4
NUVASIVE
  SUBSTANTIALLY EQUIVALENT 4
ORTHOFIX
  SUBSTANTIALLY EQUIVALENT 1
SPINAL ELEMENTS
  SUBSTANTIALLY EQUIVALENT 2
SPINE WAVE, INC.
  SUBSTANTIALLY EQUIVALENT 1
SPINEOLOGY INC.
  SUBSTANTIALLY EQUIVALENT 1
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 4
SURGICRAFT CO.
  SUBSTANTIALLY EQUIVALENT 1
THEKEN SPINE
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
No Known Device Problem 24
Break 17
Migration of device or device component 13
Disassembly 9
Fracture 9
Material deformation 7
Mechanical issue 6
No code available 5
Material integrity issue 5
Bent 5
Crack 3
Not Applicable 3
Positioning Issue 2
Unintended movement 2
Improper or incorrect procedure or method 2
Material fragmentation 2
Failure to advance 2
Malposition of device 2
Device operates differently than expected 1
Device or device component damaged by another device 1
Dislodged or dislocated 1
Device expiration issue 1
Use of Device Issue 1
Difficult to insert 1
Loose or intermittent connection 1
Collapse 1
Fitting problem 1
Incomplete or missing packaging 1
Material torqued 1
No Information 1
Device handling issue 1
Total Device Problems 131

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 1 0 3 2 0
Class III 0 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Amendia, Inc II Dec-22-2016
2 Biomet Spine, LLC II Mar-25-2016
3 Biomet Spine, LLC II Jan-15-2015
4 Biomet Spine, LLC II Jan-15-2015
5 Biomet Spine, LLC II Jan-14-2015
6 Lanx, Inc. II Nov-26-2013

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