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
Jan 31, 2001K010003EBI VUELOCK ANTERIOR CERVICAL PLATE SYSTEM
Ebi, L.P.
KWQ
Oct 30, 2000K003061SYNTHES USS (10.0MM SIDE OPENING SCREWS)
Synthes
KWQ
Oct 23, 2000K002980MODIFICATION TO EBI ANTERIOR CERVICAL PLATE SYSTEM
Ebi, L.P.
KWQ
Oct 13, 2000K002858XIA SPINE SYSTEM
Howmedica Osteonics Corp.
KWQ
Oct 6, 2000K002592INTERPORE CROSS ANTERIOR CERVICAL PLATE SYSTEM
Interpore Cross Intl.
KWQ
Sep 15, 2000K002371K-CENTRUM ANTERIOR SPINAL FIXATION SYSTEM
Spineology, Inc.
KWQ
Aug 24, 2000K001847ANTERIOR CERVICAL PLATE SYSTEM
Encore Orthopedics, Inc.
KWQ
Jul 20, 2000K001864SYNTHES CERVIFIX SYSTEM
Synthes Spine
KWQ
Jul 20, 2000K001357MODIFICATION TO OMEGA 21 SYSTEM
Ebi, L.P.
KWQ
Jul 19, 2000K001844MODIFICATION TO CENTAUR SPINAL SYSTEM
Howmedica Osteonics Corp.
KWQ
Jul 12, 2000K001794EBI ANTERIOR CERVICAL PLATE SYSTEM
Ebi, L.P.
KWQ
Jun 19, 2000K994239ZEPHIR ANTERIOR CERVICAL PLATE SYSTEM
Medtronic Sofamor Danek, Inc.
KWQ
Jun 7, 2000K993066WINDOW CERVICAL DYNAMIC PLATE SYSTEM
Advanced Spine Technology, Inc.
KWQ
May 11, 2000K001272XIA SPINE SYSTEM
Howmedica Osteonics Corp.
KWQ
Apr 26, 2000K993513DELTALOC ANTERIOR CERVICAL PLATE SYSTEM
Alphatec Mfg., Inc.
KWQ
Apr 14, 2000K000486ABC CERVICAL PLATING SYSTEM
Aesculap, Inc.
KWQ
Mar 29, 2000K000742SYNTHES ANTERIOR CSLP SYSTEM
Synthes Spine
KWQ
Mar 15, 2000K994347CENTAUR SPINAL SYSTEM
Howmedica Osteonics Corp.
KWQ
Mar 15, 2000K000536SYNTHES ANTERIOR CSLP SYSTEM
Synthes Spine
KWQ
Mar 10, 2000K000634ROD TO ROD CROSS BRACES
Corin USA
KWQ
Mar 10, 2000K000009SPIRAL RADIUS RODDING SYSTEM
United States Surgical, A Division of Tyco Healthc
KWQ
Mar 7, 2000K000513MODIFICATION TO EBI SPINELINK ANTERIOR CERVICAL SPINAL SYSTEM
Ebi, L.P.
KWQ
Feb 18, 2000K994122BONE GRAFT WASHER, MODEL 9090114 - 9090118
Danek Medical, Inc.
KWQ
Feb 4, 2000K994383DOGBONE ACFS
Theken Surgical
KWQ
Feb 4, 2000K992012WILTSE SYSTEM
Advanced Spine Fixation Systems, Inc.
KWQ
Dec 29, 1999K993030MODIFICATION TO ISOLA SPINAL SYSTEM
Depuyacromed
KWQ
Dec 27, 1999K990959K-CENTRUM ANTERIOR SPINAL FIXATION SYSTEM
Spineology, Inc.
KWQ
Dec 15, 1999K993855ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM
Danek Medical, Inc.
KWQ
Dec 10, 1999K993822EBI SPINELINK ANTERIOR CERVICAL SPINAL SYSTEM
Ebi, L.P.
KWQ
Nov 16, 1999K992792XIA SPINAL SYSTEM C-C ADAPTOR
Howmedica Osteonics Corp.
KWQ
Oct 27, 1999K992784NEXT GENERATION RODDING SYSTEM
United States Surgical, A Division of Tyco Healthc
KWQ
Oct 22, 1999K993181HOWMEDICA OSTEONICS ACCP SYSTEM CORTICAL SCREWS
Howmedica Osteonics Corp.
KWQ
Sep 23, 1999K992168MOSS MIAMI 6.35MM POLYAXIAL SCREW
Depuyacromed
KWQ
Sep 14, 1999K992110PREMIER ANTERIOR CERVICAL PLATE SYSTEM
Sofamor Danek USA
KWQ
Aug 12, 1999K991678WHITESIDE BIOMECHANICS SPINAL SYSTEM
Whiteside Biomechanics, Inc.
KWQ
Jul 30, 1999K992344OSTEONICS ACCP SYSTEM LINE EXTENSION
Howmedica Osteonics Corp.
KWQ
Apr 29, 1999K991092EBI SPINELINK ANTERIOR CERVICAL SPINAL SYSTEM
Electro-Biology, Inc.
KWQ
Mar 25, 1999K982798OSTEONICS ANTERIOR CERVICAL COMPRESSION PLATING SYSTEM
Osteonics Corp.
KWQ
Mar 10, 1999K990603MODIFICATION OF THE ZPLATE-ATL ANTERIOR FIXATION SYSTEM
Danek Medical, Inc.
KWQ
Feb 24, 1999K984251XIA SPINE SYSTEM
Howmedica, Inc.
KWQ
Feb 12, 1999K990005SPINAL CONCEPTS, INC. (SCI) ANTERIOR CERVICAL PLATE SYSTEM
Spinal Concepts, Inc.
KWQ
Jan 20, 1999K982006MICOMED - HALM ZIELKE INSTRUMENTATION
Micomed GmbH
KWQ
Jan 19, 1999K982875MODIFICATION TO ZPLATE-ATL ANTERIOR FIXATION SYSTEM
Danek Medical, Inc.
KWQ
Dec 30, 1998K984342ANTERIOR CERVICAL PLATING SYSTEM
United States Surgical, A Division of Tyco Healthc
KWQ
Dec 30, 1998K983622BODYFORM THORACO-LUMBAR FIXATION SYSTEM
Theken Surgical,Llc
KWQ
Dec 22, 1998K983899THORACOLUMBAR SPINAL ROD SYSTEM (EMPOWER)
United States Surgical, A Division of Tyco Healthc
KWQ
Jul 29, 1998K982443DOC VENTRAL CERVICAL STABILIZATION SYSTEM
Depuy Motech Acromed
KWQ
Jun 17, 1998K974885BLACKSTONE MEDICAL INC. ANTERIOR CERVICAL PLATE SYSTEM
Blackstone Medical, Inc.
KWQ
May 27, 1998K981008SIMAL CERVICAL STABILIZATION SYSTEM
Top Surgical Products GmbH
KWQ
Apr 14, 1998K980228UNIVERSITY PLATE ANTERIOR SYSTEM
Acromed Corp.
KWQ

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