Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
Device orthosis, spinal pedicle fixation
Regulation Description Pedicle screw spinal system.
Product CodeMNI
Regulation Number 888.3070
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 3
AESCULAP
  SUBSTANTIALLY EQUIVALENT 4
ALLEZ SPINE, LLC
  SUBSTANTIALLY EQUIVALENT 1
ALPHATEC
  SUBSTANTIALLY EQUIVALENT 7
BLACKSTONE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 7
DEPUY INTL., LTD.
  SUBSTANTIALLY EQUIVALENT 10
EBI, L.P.
  SUBSTANTIALLY EQUIVALENT 5
ENCORE MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 5
ENDIUS, INC.
  SUBSTANTIALLY EQUIVALENT 4
EXACTECH, INC.
  SUBSTANTIALLY EQUIVALENT 1
INTERPORE CROSS
  SUBSTANTIALLY EQUIVALENT 6
LANX
  SUBSTANTIALLY EQUIVALENT 3
LIFE SPINE
  SUBSTANTIALLY EQUIVALENT 7
MEDICREA TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 6
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 28
NUVASIVE
  SUBSTANTIALLY EQUIVALENT 1
PIONEER
  SUBSTANTIALLY EQUIVALENT 3
SOFAMOR DANEK
  SUBSTANTIALLY EQUIVALENT 5
SPINAL CONCEPTS
  SUBSTANTIALLY EQUIVALENT 5
SPINE WAVE, INC.
  SUBSTANTIALLY EQUIVALENT 7
SPINEFRONTIER, INC.
  SUBSTANTIALLY EQUIVALENT 1
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 12
SULZER
  SUBSTANTIALLY EQUIVALENT 1
SYNTHES
  SUBSTANTIALLY EQUIVALENT 11
THEKEN SPINE
  SUBSTANTIALLY EQUIVALENT 2
U&I CORP.
  SUBSTANTIALLY EQUIVALENT 1
VERTEBRON, INC.
  SUBSTANTIALLY EQUIVALENT 2
VERTIFLEX
  SUBSTANTIALLY EQUIVALENT 1
X-SPINE SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Break 46
Explanted 16
Loose 9
Migration of device or device component 5
Device remains implanted 5
Implant, removal of 5
Device or device component damaged by another device 5
Device Issue 4
Replace 4
Device, or device fragments remain in patient 3
Difficult to remove 2
Disengaged 2
Component(s), broken 2
Detachment of device component 2
Internal fixation, revision of 2
Failure to align 2
Detachment of device or device component 2
Failure to Adhere or Bond 1
No Information 1
Implant breakage or physical damage 1
Disassembly 1
Displacement 1
Fracture 1
Difficult to insert 1
Material separation 1
Sticking 1
Mechanical issue 1
Total Device Problems 126

Recalls
  2007 2008 2009 2010 2011 2012 2013
Class I 0 0 0 0 0 0 0
Class II 2 5 3 2 0 3 1
Class III 0 0 1 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Spine II Sep-01-2008
2 Allez Spine, LLC II Oct-28-2008
3 Allez Spine, LLC II Sep-17-2008
4 Allez Spine, LLC II Sep-02-2008
5 Allez Spine, LLC II Mar-11-2008
6 Blackstone Medical, Inc. II Mar-16-2010
7 Blackstone Medical, Inc. II Jul-06-2009
8 Blackstone Medical, Inc. II Dec-11-2007
9 Captiva Spine, Inc II Nov-21-2012
10 EBI, L.P. III Sep-22-2009
11 Medtronic Sofamor Danek Instrument Manufacturing II Feb-08-2007
12 Orthopedic Alliance LLC II Apr-22-2013
13 Stryker Spine II Aug-22-2012
14 Stryker Spine II Apr-10-2009
15 Synthes USA HQ, Inc. II Jul-20-2012
16 Warsaw Orthopedic, Inc. dba Medtronic SOFAMOR DANEK II Mar-12-2009
17 Zimmer Inc. II Aug-31-2010

-
-