ClearanceBrief
Panels › Orthopedic › Product code KWQ · Class 2

Appliance, Fixation, Spinal Intervertebral Body

Regulation 888.3060

11510(k)s in 12 months (668 all time)
1recalls in 12 months (214 all time)
165recalls that name a 510(k)
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Top companies in KWQ

Company510(k)sRecalls
Stryker Spine638
Alphatec Spine, Inc.932
RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)041
Zimmer, Inc.137
Medtronic Sofamor Danek298
Nuvasive, Inc.210
K2m200
Depuy Spine, Inc.108
Blackstone Medical, Inc.133
Globus Medical, Inc.150
Decided510(k)Device and applicantCode
Apr 11, 2005K050774LANX ANTERIOR CERVICAL PLATE SYSTEM
Lanx, LLC
KWQ
Mar 24, 2005K050451SYNTHES VECTRA SYSTEM
Synthes Spine Co.Lp
KWQ
Mar 14, 2005K050390TAMARACK ANTERIOR THORACOLUNBAR
Alphatec/Nexmed
KWQ
Feb 17, 2005K050117MODIFICATION TO PYRAMID ANTERIOR PLATE FIXATION SYSTEM
Medtronic Sofamor Danek
KWQ
Feb 7, 2005K042073OLSEN MEDICAL ANTERIOR CERVICAL VERTEBRAE PLATE SYSTEM
Olsen Medical
KWQ
Feb 3, 2005K043066PIONEER ANTERIOR CERVICAL PLATE SYSTEM
Pioneer Surgical Technology
KWQ
Feb 1, 2005K043151MODIFICATION TO: CD HORIZON SPINAL SYSTEM
Medtronic Sofamor Danek
KWQ
Feb 1, 2005K031782GAPP GRAFT CONTIANMENT DEVICE ORTHOPEDICS
Medtronic Sofamor Danek
KWQ
Dec 17, 2004K043181MODIFICATION TO VERTEBRON SCP CERVICAL PLATE SYSTEM
Vertebron, Inc.
KWQ
Dec 17, 2004K040426TRANS1 AXIAL FIXATION SYSTEM
Trans1, Inc.
KWQ
Nov 24, 2004K042859KOBRA GPS FIXATION SYSTEM
Medtronic Vertelink, Inc.
KWQ
Nov 23, 2004K043082THE TOSCA ANTERIOR CERVICAL PLATE SYSTEM
Signus Medizintechnik GmbH
KWQ
Nov 23, 2004K042544UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM
Depuy Spine, Inc.
KWQ
Nov 19, 2004K042922VENTURE ANTERIOR CERVICAL PLATING SYSTEM
Medtronic Sofamor Danek, Inc.
KWQ
Nov 4, 2004K042798C-TEK C-TRUN ANTERIOR CERVICAL PLATE SYSTEM
Interpore Cross Intl.
KWQ
Oct 7, 2004K042499ORION ANTERIOR CERVICAL PLATING SYSTEM
Medtronic Sofamor Danek
KWQ
Sep 24, 2004K042317CERVICAL PLATE
Scient'X
KWQ
Sep 17, 2004K042235ORION ANTERIOR CERVICAL PLATING SYSTEM
Medtronic Sofamor Danek
KWQ
Sep 16, 2004K041989SINTEA BIOTECH ANTERIOR PLATE SYSTEM, MODEL ACP.XX.T5.X
Sintea Biotech, Inc.
KWQ
Sep 8, 2004K041625LTD POLYAXIAL FIXATION SYSTEM
Us Spinal Technologies, LLC
KWQ
Aug 25, 2004K042025MODIFICATION TO CD HORIZON SPINAL SYSTEM
Medtronic Sofamor Danek, Inc.
KWQ
Aug 17, 2004K041205EXPEDIUM ANTERIOR SPINE SYSTEM
Depuy Spine, Inc.
KWQ
Aug 16, 2004K041447NUVASIVE ANTERIOR CERVICAL PLATE SYSTEM
Nuvasive, Inc.
KWQ
Jul 30, 2004K041469ANTERIOR COMPACT SYSTEM
X-Spine Systems
KWQ
Jul 28, 2004K041105MACROPORE HYDROSORB SPINE SYSTEM
Macropore Biosurgery, Inc.
KWQ
Jul 23, 2004K040844LIFE SPINE NEO ANTERIOR CERVICAL PLATE SYSTEM
Life Spine, LLC
KWQ
Jul 19, 2004K041794C-TEK C-THRU ANTERIOR CERVICAL PLATE SYSTEM
Interpore Cross Intl.
KWQ
Jul 1, 2004K041460CD HORIZON SPINAL SYSTEM
Medtronic Sofamor Danek USA, Inc.
KWQ
Jul 1, 2004K033951RADIX CERVICAL PLATE
Pisharodi Surgicals, Inc.
KWQ
Jun 17, 2004K040721ASSURE ANTERIOR CERVICAL PLATE SYSTEM
Globus Medical, Inc.
KWQ
Jun 2, 2004K040655SWIFT ANTERIOR CERVICAL PLATE SYSTEM
Depuy Spine, Inc.
KWQ
May 28, 2004K041217MODIFICATION TO BONE GRAFT WASHER
Medtronic Sofamor Danek, Inc.
KWQ
May 14, 2004K040962MODIFICATION TO CD HORIZON SPINAL SYSTEM
Medtronic Sofamor Danek
KWQ
May 14, 2004K040017ABC CAUDAL AND CRANIAL EXTENSION PLATE (E-PLATE)
Aesculap, Inc.
KWQ
May 6, 2004K040397MODIFICATION TO CYCLONE ANTERIOR CERVICAL PLATE SYSTEM
Encore Medical L.P.
KWQ
Apr 16, 2004K040261REFLEX HYBRID ANTERIOR CERVICAL PLATE SYSTEM
Stryker Spine
KWQ
Apr 12, 2004K040401LANX ANTERIOR CERVIAL PLATE SYSTEM
Lanx, LLC
KWQ
Apr 12, 2004K033148ART ANTERIOR SPINAL SYSTEM
Advanced Medical Technologies AG
KWQ
Apr 2, 2004K040197EAGLE ANTERIOR CERVIAL PLATE SYSTEM
Depuyacromed
KWQ
Mar 26, 2004K040130ANTERIOR LUMBAR BUTTRESS SYSTEM
Seaspine
KWQ
Mar 26, 2004K040003VERTEBRON SCP CERVICAL PLATE SYSTEM
Vertebron, Inc.
KWQ
Mar 4, 2004K033965SHIRAZ-ANTERIOR SYSTEM
Spine Next America
KWQ
Mar 4, 2004K031100SYNTHES VENTROFIX MIS SYSTEM
Synthes (Usa)
KWQ
Feb 12, 2004K032815PRECISION SURGERY LIMITED VARIABLE AND FIXED CERVICAL PLATE SYSTEM
Precision Surgery Limited
KWQ
Feb 5, 2004K033844SYNTHES ANTERIOR CERVICAL COMPRESSION SYSTEM
Synthes (Usa)
KWQ
Dec 12, 2003K032102VERTELINK KOBRA SPINAL FIXATION SYSTEM
Vertelink Corporation
KWQ
Dec 3, 2003K032752R&B SURGICAL SMARTPLATE CERVICAL PLATE SYSTEM
R&B Surgical Solutions, LLC
KWQ
Oct 9, 2003K032368SONOMA ANTERIOR CERVICAL PLATE SYSTEM
Seaspine
KWQ
Sep 23, 2003K031214CYCLONE ANTERIOR CERVICAL PLATE SYSTEM
Encore Medical L.P.
KWQ
Sep 22, 2003K024125HALM ZIELKE INSTRUMENTATION SYSTEM
Micomed Ortho GmbH
KWQ

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