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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
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 47
No Known Device Problem 18
Device operates differently than expected 16
Migration of device or device component 16
Mechanical issue 11
Detachment of device or device component 11
Unintended movement 8
Fitting problem 7
Detachment of device component 7
Material fragmentation 7
Fracture 6
Dislodged or dislocated 6
Difficult to advance 4
Loose or intermittent connection 4
Material deformation 3
Material integrity issue 3
Failure to Adhere or Bond 3
Difficult to insert 3
Disassembly 3
Not Applicable 3
Peeled 2
Material separation 2
Mechanical jam 2
Failure to align 2
Failure to separate 1
Malposition of device 1
Patient-device incompatibility 1
Component or accessory incompatibility 1
Device or device component damaged by another device 1
Packaging issue 1
Slippage of device or device component 1
Sticking 1
Use of Device Issue 1
Component missing 1
Device Issue 1
Dull 1
Disconnection 1
Crack 1
No Information 1
No code available 1
Total Device Problems 210

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

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

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