KWP · Class II · 21 CFR 888.3050

FDA Product Code KWP: Appliance, Fixation, Spinal Interlaminal

Leading manufacturers include Medtronic Sofamor Danek, Medtronic Sofamor Danek, Inc. and Synthes (Usa).

430
Total
430
Cleared
130d
Avg days
1978
Since
430 devices
169–192 of 430
Cleared Mar 26, 2004
ICON POLYAXIAL PEDICLE SCREW SYSTEM
K033090
Alphatec Mfg., Inc.
Orthopedic · 179d
Cleared Mar 03, 2004
BLACKSTONE ASCENT POCT SYSTEM HOOKS (SYSTEM MODIFICATION)
K033980
Blackstone Medical, Inc.
Orthopedic · 71d
Cleared Nov 14, 2003
CLICK'X MONOAXIAL SCREWS AND HOOKS
K031175
Synthes (Usa)
Orthopedic · 214d
Cleared Nov 14, 2003
PASSMED SPINAL SYSTEM
K032094
Medicrea
Orthopedic · 130d
Cleared Oct 10, 2003
ORIA SPINAL CLIP SYSTEM, LATERAL INTERMEDIATE CONNECTOR, MODEL AL01
K031471
Ortho Tec, LLC
Orthopedic · 154d
Cleared Sep 05, 2003
TI FENESTRATED PLATE
K031772
Interpore Cross Intl.
Orthopedic · 88d
Cleared Aug 20, 2003
MODIFICATION ORIA SPINAL SYSTEM
K023884
Ortho Tec, LLC
Orthopedic · 272d
Cleared Jul 17, 2003
XIA SPINAL SYSTEM AND XIA STAINLESS STEEL SYSTEM
K031893
Howmedica Osteonics Corp.
Orthopedic · 28d
Cleared Jun 24, 2003
MODIFICATION TO COLORADO 2 SPINAL SYSTEM
K030875
Medtronic Sofamor Danek, Inc.
Orthopedic · 96d
Cleared Jun 24, 2003
U & I AMERICA SPINAL HOOK SYSTEM
K031595
U&I Corp., America
Orthopedic · 34d
Cleared Jun 18, 2003
ORIA SPINAL CLIP SYSTEM, SACRAL CONNECTOR, MODELS CA03 AND AO03
K031452
Ortho Tec, LLC
Orthopedic · 42d
Cleared Jun 13, 2003
VANTAGE ANTERIOR FIXATION SYSTEM
K031533
Medtronic Sofamor Danek, Inc.
Orthopedic · 28d
Cleared Jun 12, 2003
BLACKSTONE POSTERIOR CERVICAL SYSTEM
K030197
Blackstone Medical, Inc.
Orthopedic · 142d
Cleared Jun 06, 2003
MSD CABLE REDUCTION SYSTEM
K030816
Medtronic Sofamor Danek
Orthopedic · 84d
Cleared Apr 24, 2003
MODIFICATION TO XIA STAINLESS STEEL SYSTEM
K031090
Howmedica Osteonics Corp.
Orthopedic · 17d
Cleared Feb 21, 2003
MODIFICATION TO BLACKSTONE SPINAL FIXATION SYSTEM
K030241
Blackstone Medical, Inc.
Orthopedic · 29d
Cleared Feb 21, 2003
ORIA SPINAL CLIP SYSTEM EXTENDED OMNIAXIAL CONNECTORS (CO05 & CO07)
K030252
Ortho Tec, LLC
Orthopedic · 28d
Cleared Feb 21, 2003
ORIA SPINAL CLIP SYSTEM, LENGTHENED LATERAL CONNECTOR, MODEL AL06
K030253
Ortho Tec, LLC
Orthopedic · 28d
Cleared Jan 23, 2003
MOSS MIAMI SPINAL SYSTEM PIN NUT
K023804
Depuyacromed
Orthopedic · 70d
Cleared Dec 13, 2002
MODIFICATION TO DYNALOK CLASSIC SPINAL SYSTEM
K023415
Medtronic Sofamor Danek
Orthopedic · 63d
Cleared Dec 13, 2002
LAURAIN DEWALD ANTERIOR FIXATION SYSTEM
K023797
Medtronic Sofamor Danek
Orthopedic · 29d
Cleared Dec 10, 2002
CD HORIZON SPINAL SYSTEM
K014296
Medtronic Sofamor Danek
Orthopedic · 344d
Cleared Dec 04, 2002
INTERPORE CROSS INTERNATIONAL (ICI) OCCIPITO-CERVICO-THORACIC (OCT) ROD AND PLATE SYSTEM
K022048
Interpore Cross Intl.
Orthopedic · 163d
Cleared Nov 26, 2002
SYNTHES CERVIFIX/ AXON
K023675
Synthes (Usa)
Orthopedic · 25d