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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 bone graft, cervical
Regulation Description Intervertebral body fusion device.
Definition Intended to stabilize cervical spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.
Product CodeODP
Regulation Number 888.3080
Device Class 2


Premarket Reviews
ManufacturerDecision
ACKERMANN INSTRUMENTE GMBH
  SUBSTANTIALLY EQUIVALENT 1
AESCULAP
  SUBSTANTIALLY EQUIVALENT 1
ALPHATEC
  SUBSTANTIALLY EQUIVALENT 1
ATLAS SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 1
CUSTOM SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 1
EXACTECH, INC.
  SUBSTANTIALLY EQUIVALENT 3
GLOBUS
  SUBSTANTIALLY EQUIVALENT 2
INNOVASIS, INC.
  SUBSTANTIALLY EQUIVALENT 1
K2M
  SUBSTANTIALLY EQUIVALENT 1
LANX
  SUBSTANTIALLY EQUIVALENT 1
LIFE SPINE
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 9
NUVASIVE
  SUBSTANTIALLY EQUIVALENT 2
ORTHO DEVELOPMENT
  SUBSTANTIALLY EQUIVALENT 1
ORTHOFIX
  SUBSTANTIALLY EQUIVALENT 4
ORTHOVITA
  SUBSTANTIALLY EQUIVALENT 1
PIONEER
  SUBSTANTIALLY EQUIVALENT 1
SPINAL DEVICES, LLC
  SUBSTANTIALLY EQUIVALENT 1
SPINAL ELEMENTS
  SUBSTANTIALLY EQUIVALENT 1
SPINEFRONTIER, INC.
  SUBSTANTIALLY EQUIVALENT 4
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 3
THEKEN SPINE
  SUBSTANTIALLY EQUIVALENT 1
U&I CORP.
  SUBSTANTIALLY EQUIVALENT 2
X-SPINE SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 3

Device Problems
No Known Device Problem 25
Break 23
Fracture 13
Migration of device or device component 10
Improper or incorrect procedure or method 5
Mechanical issue 4
No Information 2
Malposition of device 2
Material deformation 2
Unintended movement 2
Implant breakage or physical damage 2
Device operates differently than expected 2
Bent 1
Difficult to remove 1
Physical resistance 1
Defective component 1
Material integrity issue 1
Misassembled 1
Use of Device Issue 1
Deployment issue 1
Dislodged or dislocated 1
No code available 1
Detachment of device component 1
Size incorrect for patient 1
Misassembled by Users 1
Material separation 1
Out-of-box failure 1
Device or device component damaged by another device 1
Positioning Issue 1
Total Device Problems 109

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

Recalls
Manufacturer Recall Class Date Posted
1 Exactech, Inc. II Jul-31-2012
2 RTI Surgical, Inc. II Jan-03-2014
3 SpineNet II Aug-27-2013
4 Synthes Spine II Jun-10-2009
5 Synthes USA (HQ), Inc. II Oct-21-2011

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