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
217–240 of 430
Cleared Sep 12, 2000
MOSS MIAMI 6.35MM ROD SYSTEM MONOAXIAL SCREWS, POLYAXIAL REDUCTION SCREWS AND SACRAL EXTENDERS
K002607
Depuyacromed
Orthopedic · 21d
Cleared Aug 18, 2000
XIA SPINE SYSTEM SACRAL BLOCK ASSEMBLY
K001653
Howmedica Osteonics Corp.
Orthopedic · 80d
Cleared Aug 04, 2000
E-Z LINK CROSS CONNECTOR
K001470
Depuyacromed
Orthopedic · 85d
Cleared Jul 27, 2000
E-Z LINK CROSS CONNECTOR
K001372
Depuyacromed
Orthopedic · 87d
Cleared Jun 29, 2000
SPINE SYSTEM EVOLUTION
K001080
Aesculap, Inc.
Orthopedic · 86d
Cleared Jun 16, 2000
DYNA-LOK CLASSIC SPINAL SYSTEM
K001532
Medtronic Sofamor Danek, Inc.
Orthopedic · 30d
Cleared Apr 24, 2000
MOSS MIAMI 6.35MM ROD SYSTEM PEDICLE AND LAMINAR HOOKS
K001105
Depuyacromed
Orthopedic · 19d
Cleared Dec 21, 1999
SYNTHES CERVIFIX SYSTEM
K994187
Synthes (Usa)
Orthopedic · 8d
Cleared Nov 19, 1999
VERSALOK LOW BACK FIXATION SYSTEM
K992885
Osteotech, Inc.
Orthopedic · 84d
Cleared Nov 16, 1999
SILHOUETTE SPINAL FIXATION SYSTEM
K993067
Sulzer Spine-Tech
Orthopedic · 64d
Cleared Nov 08, 1999
TITANIUM HARTSHILL SYSTEM
K991662
Surgicraft , Ltd.
Orthopedic · 178d
Cleared Oct 14, 1999
CONTOUR SPINAL SYSTEM
K990986
Ortho Development Corp.
Orthopedic · 204d
Cleared Aug 27, 1999
SYNTHES CERVIFIX SYSTEM
K991089
Synthes Spine
Orthopedic · 149d
Cleared Aug 27, 1999
DYNA-LOK PLUS SPINAL SYSTEM
K991198
Sofamor Danek USA,Inc.
Orthopedic · 141d
Cleared Jul 23, 1999
SSCS (SEGMENTAL SPINAL CORRECTION SYSTEM)
K991586
Osteotech, Inc.
Orthopedic · 77d
Cleared Jul 01, 1999
SYNTHES CERVIFIX SYSTEM
K990965
Synthes (Usa)
Orthopedic · 101d
Cleared Jun 02, 1999
OSTEONICS SPINAL SYSTEM VERSATILE CROSS CONNECTOR
K990922
Howmedica Osteonics Corp.
Orthopedic · 75d
Cleared Apr 30, 1999
OSTEONICS SPINAL SYSTEM - SACRAL OFFSET CONNECTOR ASSEMBLY
K984375
Osteonics Corp.
Orthopedic · 144d
Cleared Apr 29, 1999
EBI OMEGA 21 SYSTEM
K990303
Electro-Biology, Inc.
Orthopedic · 87d
Cleared Apr 13, 1999
MODIFICATION TO PARTS NUMBERED CGT-SL AND CGT-SL-15
K990845
Advanced Spine Fixation Systems, Inc.
Orthopedic · 29d
Cleared Mar 30, 1999
TITANIUM VERSALOK
K990708
Wrightmedicaltechnologyinc
Orthopedic · 26d
Cleared Jan 28, 1999
CD HORIZON SPINAL SYSTEM
K981676
Sofamor Danek USA,Inc.
Orthopedic · 261d
Cleared Jan 21, 1999
SYNTHES SPINE CERVIFIX SYSTEM
K984377
Synthes (Usa)
Orthopedic · 49d
Cleared Dec 22, 1998
ROGOZINSKI SPINAL ROD SYSTEM
K983904
United States Surgical, A Division of Tyco Healthc
Orthopedic · 49d