ClearanceBrief
Panels › Orthopedic › Product code KWP · Class 2

Appliance, Fixation, Spinal Interlaminal

Regulation 888.3050

0510(k)s in 12 months (430 all time)
0recalls in 12 months (68 all time)
65recalls that name a 510(k)
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Top companies in KWP

Company510(k)sRecalls
Medtronic Sofamor Danek5412
Synthes (Usa)170
Zimmer, Inc.710
Danek Medical, Inc.160
K2m123
Acromed Corp.140
Seaspine, Inc.310
Sofamor Danek USA,Inc.130
Depuy, Inc.110
Alphatec Spine, Inc.46
Decided510(k)Device and applicantCode
Jul 22, 2002K022070XANTUS ANTERIOR LATERAL SUPPLEMENTAL FIXATION SYSTEM
Medtronic Sofamor Danek, Inc.
KWP
Jul 18, 2002K022015MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM
Medtronic Sofamor Danek, Inc.
KWP
Jul 9, 2002K021170TSRH SPINAL SYSTEM
Medtronic Sofamor Danek USA, Inc.
KWP
Jul 3, 2002K021919SCS CLARIS SPINAL SYSTEM,REXTENDED OMNIAXIAL CONNECTOR-,MEDIUM, MODEL CO05, SCS CLARIS SPINAL SYSTEM,EXTENDED OMNIAXIALO
Ortho Tec, LLC
KWP
Jul 1, 2002K021825MODIFICATION TO SPIRAL RADIUS 90-D SST SYSTEM
Unitedstates Surgical
KWP
Jun 18, 2002K021009OCTAFIX OCCIPITAL CERVICAL PLATING SYSTEM
Spinal Concepts, Inc.
KWP
May 9, 2002K020709MODIFICATION TO CD HORIZON SPINAL SYSTEM
Medtronic Sofamor Danek
KWP
Apr 15, 2002K020134SPIRAL RADIUS 90-D RODDING SYSTEM
United States Surgical, A Division of Tyco Healthc
KWP
Mar 11, 2002K014090ENDIUS SPINAL FIXATION SYSTEM
Endius, Inc.
KWP
Feb 26, 2002K020426MSD WIRE SYSTEM
Medtronic Sofamor Danek, Inc.
KWP
Feb 14, 2002K020236MODIFICATION TO PASS SPINAL SYSTEM
Encore Orthopedics, Inc.
KWP
Feb 13, 2002K013312P.L.U.S. SYSTEM (PIVOT LINK UNIVERSAL SYSTEM)
Spine Vision, Inc.
KWP
Feb 5, 2002K020155DYNA-LOK CLASSIC SPINAL SYSTEM
Medtronic Sofamor Danek
KWP
Jan 30, 2002K013196ASCEND SPINAL FIXATION SYSTEM WITH THE SHADOW SPINAL SYSTEM
Spinal Innovations, LLC
KWP
Jan 25, 2002K014267BUTTERFLY PLATE FIXATION SYSTEM
Medtronic Sofamor Danek, Inc.
KWP
Jan 15, 2002K013447ISOBAR SPINAL SYSTEM
Scien'Tx USA, Inc.
KWP
Jan 15, 2002K013442PASS SPINAL SYSTEM
Encore Orthopedics, Inc.
KWP
Dec 19, 2001K013823XIA SPINAL SYSTEM
Howmedica Osteonics Corp.
KWP
Nov 27, 2001K012516EBI SPINELINK - II SPINAL FIXATION SYSTEM
Ebi, L.P.
KWP
Nov 16, 2001K013441ISOLA POLYAXIAL WASHER
Depuyacromed
KWP
Sep 28, 2001K012173DEVICE MODIFICATION OF SILHOUETTE SPINDAL FIXATION SYSTEM
Sulzer Spine-Tech
KWP
Sep 28, 2001K003780VERTEX RECONSTRUCTION SYSTEM
Medtronic Sofamor Danek, Inc.
KWP
Sep 24, 2001K012870XIA STAINLESS STEEL SYSTEM
Howmedica Osteonics Corp.
KWP
Sep 13, 2001K012871SYNERGY TI INTEGRAL OPEN SCREWS MODELS # 6193, 6194, 6195,6196, 6173, 6174, 6175, 6176, 6177
Interpore Cross Intl.
KWP
Jul 23, 2001K011830TRI-FIX SPINAL FIXATION SYSTEM
Endius, Inc.
KWP
Jul 19, 2001K011969SYNTHES CERVIFIX SYSTEM
Synthes (Usa)
KWP
Jul 18, 2001K010681SUMMIT OCCIPITO-CERVICO-THORACIC (OCT) SPINAL SYSTEM
Depuyacromed
KWP
Jul 11, 2001K003823SCS DT-02 TRANSVERSE CONNECTOR
Ortho Tec, LLC
KWP
Jun 12, 2001K011508CD HORIZON SPINAL SYSTEM
Medtronic Sofamor Danek, Inc.
KWP
Jun 12, 2001K010181CD HORIZON SPINAL SYSTEM, 4.5 ROD FOR POSTERIOR APPLICATION
Medtronic Sofamor Danek, Inc.
KWP
May 31, 2001K010632BUTTERFLY PLATE FUNCTION SYSTEM
Medtronic Sofamor Danek USA, Inc.
KWP
Mar 22, 2001K010515MODIFICATION TO SYNERGY SPINAL SYSTEM
Interpore Cross Intl.
KWP
Mar 20, 2001K001535ZENITH PLATE SYSTEM, ANTERIOR SPINAL INSTRUMENTATION
Ortho Tec, LLC
KWP
Mar 13, 2001K003911TERRAY STAINLESS STEEL ROD (STRAIGHT, L, RECTANGLE)
Terray Corp., CA
KWP
Jan 24, 2001K003351PARSFIX CABLE-SCREW SYSTEM
Spinal Concepts, Inc.
KWP
Jan 8, 2001K003822ISOLA CLOSED DUAL ROD CONNECTOR
Depuyacromed
KWP
Dec 15, 2000K002733SUMMIT OCCIPITO-CERVICO-THORACIC (OCT) SPINAL SYSTEM
Depuyacromed
KWP
Nov 13, 2000K002059AMT SPINAL SYSTEM
Micron Precision Engineering, Inc.
KWP
Nov 2, 2000K002103SIMPLICITY SPINAL SYSTEM
Medtronic Sofamor Danek USA, Inc.
KWP
Oct 16, 2000K002959MODIFICATION TO ISOBAR SPINAL SYSTEM
Encore Orthopedics, Inc.
KWP
Oct 6, 2000K002082SPEEDLINK TRANSVERSE CONNECTOR
Spinal Concepts, Inc.
KWP
Oct 5, 2000K002505XIA SPINE SYSTEM
Howmedica Osteonics Corp.
KWP
Oct 5, 2000K002069ASCEND SPINAL FIXATION SYSTEM
Spinal Innovations, LLC
KWP
Sep 12, 2000K002607MOSS MIAMI 6.35MM ROD SYSTEM MONOAXIAL SCREWS, POLYAXIAL REDUCTION SCREWS AND SACRAL EXTENDERS
Depuyacromed
KWP
Sep 12, 2000K002517USS VAS
Synthes (Usa)
KWP
Aug 18, 2000K001653XIA SPINE SYSTEM SACRAL BLOCK ASSEMBLY
Howmedica Osteonics Corp.
KWP
Aug 4, 2000K001470E-Z LINK CROSS CONNECTOR
Depuyacromed
KWP
Jul 27, 2000K001372E-Z LINK CROSS CONNECTOR
Depuyacromed
KWP
Jun 29, 2000K001080SPINE SYSTEM EVOLUTION
Aesculap, Inc.
KWP
Jun 16, 2000K001532DYNA-LOK CLASSIC SPINAL SYSTEM
Medtronic Sofamor Danek, Inc.
KWP

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