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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
AMENDIA, INC.
  SUBSTANTIALLY EQUIVALENT 1
BIOGENNIX, LLC
  SUBSTANTIALLY EQUIVALENT 1
BIOMET
  SUBSTANTIALLY EQUIVALENT 1
CAMBER SPINE/MEDICAL TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 2
CENTINEL SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 3
CHOICE SPINE, LP
  SUBSTANTIALLY EQUIVALENT 1
CUSTOM SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 1
FBC DEVICE APS
  SUBSTANTIALLY EQUIVALENT 1
FLEXTRONICS INTERNATIONAL USA, INC.
  SUBSTANTIALLY EQUIVALENT 2
FRONTIER MEDICAL DEVICES, INC.
  SUBSTANTIALLY EQUIVALENT 1
GLOBUS
  SUBSTANTIALLY EQUIVALENT 5
GLOBUS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
INNOVASIS, INC.
  SUBSTANTIALLY EQUIVALENT 2
K2M
  SUBSTANTIALLY EQUIVALENT 1
K2M, INC.
  SUBSTANTIALLY EQUIVALENT 2
LDR SPINE USA INC.
  SUBSTANTIALLY EQUIVALENT 1
LDR SPINE USA, INC.
  SUBSTANTIALLY EQUIVALENT 1
LIFE SPINE
  SUBSTANTIALLY EQUIVALENT 1
MEDACTA INTERNATIONAL
  SUBSTANTIALLY EQUIVALENT 1
MEDACTA INTERNATIONAL SA
  SUBSTANTIALLY EQUIVALENT 2
MEDICREA INTERNATIONAL S.A.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC SOFAMOR DANEK
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 2
NEUROSTRUCTURES, INC
  SUBSTANTIALLY EQUIVALENT 2
NUVASIVE, INCORPORATED
  SUBSTANTIALLY EQUIVALENT 5
ORTHOFIX
  SUBSTANTIALLY EQUIVALENT 1
ORTHOFIX INC.
  SUBSTANTIALLY EQUIVALENT 1
OSTEO VASIVE LLC
  SUBSTANTIALLY EQUIVALENT 1
RELIANCE MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
RENOVIS SURGICAL TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
RENOVIS SURGICAL TECHNOLOGIES INC.
  SUBSTANTIALLY EQUIVALENT 1
RENOVIS SURGICAL TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 2
SEASPINE ORTHOPEDICS CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
SIATS, LLC
  SUBSTANTIALLY EQUIVALENT 1
SPINE WAVE, INC.
  SUBSTANTIALLY EQUIVALENT 1
SPINEART
  SUBSTANTIALLY EQUIVALENT 2
SPINEOLOGY INC.
  SUBSTANTIALLY EQUIVALENT 4
SPINEOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 4
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 3
STRYKER CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
SURGICAL INSTRUMENT MANUFACTURERS, LLC
  SUBSTANTIALLY EQUIVALENT 1
TITAN SPINE, LLC
  SUBSTANTIALLY EQUIVALENT 1
X-SPINE SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
X-SPINE SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
XTANT MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
ZAVATION, LLC
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER BIOMET SPINE INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Adverse Event Without Identified Device or Use Problem 83
Break 67
Fracture 28
Migration or Expulsion of Device 23
No Apparent Adverse Event 20
Migration 18
Screw 14
Positioning Problem 12
Unintended Movement 12
Disassembly 10
Material Deformation 8
Appropriate Term/Code Not Available 8
Device-Device Incompatibility 7
Mechanical Problem 7
Insufficient Information 6
Material Integrity Problem 6
Bent 6
Device Handling Problem 5
Crack 5
Difficult to Insert 5
Device Appears to Trigger Rejection 4
Knife 3
Material Twisted / Bent 3
Device Operates Differently Than Expected 3
Material Fragmentation 3
Positioning Failure 3
Improper or Incorrect Procedure or Method 3
Malposition of device 2
Loose or Intermittent Connection 2
Detachment of Device or device Component 2
Failure to Align 2
Failure to Advance 2
Difficult to Advance 2
Tip 2
Split 1
Use of Device Problem 1
Device Dislodged or Dislocated 1
Spacer 1
Device Expiration Issue 1
Device Damaged by Another Device 1
Fitting Problem 1
Detachment Of Device Component 1
Disconnection 1
Collapse 1
Patient-Device Incompatibility 1
Plate 1
Material Torqued 1
Device Component Or Accessory 1
Entrapment of Device 1
Device Difficult to Maintain 1
Device Slipped 1
Incomplete or Missing Packaging 1
Expiration Date Error 1
Total Device Problems 405

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 VGI Medical, LLC II Jun-05-2018

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