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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, 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 with or without supplemental fixation.
Product CodeOVE
Regulation Number 888.3080
Device Class 2


Premarket Reviews
ManufacturerDecision
AESCULAP
  SUBSTANTIALLY EQUIVALENT 1
BIOMET
  SUBSTANTIALLY EQUIVALENT 2
EBI, L.P.
  SUBSTANTIALLY EQUIVALENT 1
EXACTECH, INC.
  SUBSTANTIALLY EQUIVALENT 1
GLOBUS
  SUBSTANTIALLY EQUIVALENT 3
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 4
NUVASIVE
  SUBSTANTIALLY EQUIVALENT 1
ORTHOFIX
  SUBSTANTIALLY EQUIVALENT 2
SPINAL ELEMENTS
  SUBSTANTIALLY EQUIVALENT 3
SPINE WAVE, INC.
  SUBSTANTIALLY EQUIVALENT 2
SPINEFRONTIER, INC.
  SUBSTANTIALLY EQUIVALENT 2
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 1
SURGICRAFT CO.
  SUBSTANTIALLY EQUIVALENT 1
SYNTHES
  SUBSTANTIALLY EQUIVALENT 1
THEKEN SPINE
  SUBSTANTIALLY EQUIVALENT 1
X-SPINE SYSTEMS
  SUBSTANTIALLY EQUIVALENT 2
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Break 72
No Known Device Problem 31
Device operates differently than expected 19
Mechanical issue 18
Migration of device or device component 16
Detachment of device or device component 14
Detachment of device component 12
Unintended movement 12
Fracture 10
Material fragmentation 10
Fitting problem 6
Material integrity issue 6
Difficult to advance 4
Material separation 4
Loose or intermittent connection 4
Crack 4
Disassembly 3
Failure to Adhere or Bond 3
Difficult to insert 3
Material deformation 3
Mechanical jam 3
Not Applicable 3
No Information 2
Dislodged or dislocated 2
Peeled 2
Failure to align 2
Device or device component damaged by another device 2
Malposition of device 2
Patient-device incompatibility 1
Component or accessory incompatibility 1
Failure to separate 1
Packaging issue 1
Scratched material 1
Disconnection 1
Material erosion 1
Size incorrect for patient 1
Slippage of device or device component 1
Sticking 1
Use of Device Issue 1
Improper or incorrect procedure or method 1
Component missing 1
Device Issue 1
Dull 1
No code available 1
Total Device Problems 288

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

Recalls
Manufacturer Recall Class Date Posted
1 Amendia, Inc II Jan-09-2017
2 Ebi, Llc II Dec-24-2014
3 Exactech, Inc. II Feb-13-2016
4 Synthes USA HQ, Inc. II Dec-05-2013
5 TITAN SPINE, LLC II Aug-03-2015
6 TITAN SPINE, LLC II Mar-26-2015

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