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
193–216 of 430
Cleared Jan 15, 2002
PASS SPINAL SYSTEM
K013442
Encore Orthopedics, Inc.
Orthopedic · 90d
Cleared Dec 19, 2001
XIA SPINAL SYSTEM
K013823
Howmedica Osteonics Corp.
Orthopedic · 30d
Cleared Nov 27, 2001
EBI SPINELINK - II SPINAL FIXATION SYSTEM
K012516
Ebi, L.P.
Orthopedic · 113d
Cleared Nov 16, 2001
ISOLA POLYAXIAL WASHER
K013441
Depuyacromed
Orthopedic · 30d
Cleared Sep 28, 2001
VERTEX RECONSTRUCTION SYSTEM
K003780
Medtronic Sofamor Danek, Inc.
Orthopedic · 295d
Cleared Sep 24, 2001
XIA STAINLESS STEEL SYSTEM
K012870
Howmedica Osteonics Corp.
Orthopedic · 28d
Cleared Sep 13, 2001
SYNERGY TI INTEGRAL OPEN SCREWS MODELS # 6193, 6194, 6195,6196, 6173, 6174, 6175, 6176, 6177
K012871
Interpore Cross Intl.
Orthopedic · 17d
Cleared Jul 23, 2001
TRI-FIX SPINAL FIXATION SYSTEM
K011830
Endius, Inc.
Orthopedic · 41d
Cleared Jul 19, 2001
SYNTHES CERVIFIX SYSTEM
K011969
Synthes (Usa)
Orthopedic · 24d
Cleared Jul 18, 2001
SUMMIT OCCIPITO-CERVICO-THORACIC (OCT) SPINAL SYSTEM
K010681
Depuyacromed
Orthopedic · 133d
Cleared Jul 11, 2001
SCS DT-02 TRANSVERSE CONNECTOR
K003823
Ortho Tec, LLC
Orthopedic · 212d
Cleared Jun 12, 2001
CD HORIZON SPINAL SYSTEM, 4.5 ROD FOR POSTERIOR APPLICATION
K010181
Medtronic Sofamor Danek, Inc.
Orthopedic · 144d
Cleared Jun 12, 2001
CD HORIZON SPINAL SYSTEM
K011508
Medtronic Sofamor Danek, Inc.
Orthopedic · 27d
Cleared May 31, 2001
BUTTERFLY PLATE FUNCTION SYSTEM
K010632
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 90d
Cleared Mar 22, 2001
MODIFICATION TO SYNERGY SPINAL SYSTEM
K010515
Interpore Cross Intl.
Orthopedic · 28d
Cleared Mar 20, 2001
ZENITH PLATE SYSTEM, ANTERIOR SPINAL INSTRUMENTATION
K001535
Ortho Tec, LLC
Orthopedic · 307d
Cleared Jan 24, 2001
PARSFIX CABLE-SCREW SYSTEM
K003351
Spinal Concepts, Inc.
Orthopedic · 90d
Cleared Jan 08, 2001
ISOLA CLOSED DUAL ROD CONNECTOR
K003822
Depuyacromed
Orthopedic · 28d
Cleared Dec 15, 2000
SUMMIT OCCIPITO-CERVICO-THORACIC (OCT) SPINAL SYSTEM
K002733
Depuyacromed
Orthopedic · 105d
Cleared Nov 02, 2000
SIMPLICITY SPINAL SYSTEM
K002103
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 113d
Cleared Oct 16, 2000
MODIFICATION TO ISOBAR SPINAL SYSTEM
K002959
Encore Orthopedics, Inc.
Orthopedic · 24d
Cleared Oct 06, 2000
SPEEDLINK TRANSVERSE CONNECTOR
K002082
Spinal Concepts, Inc.
Orthopedic · 88d
Cleared Oct 05, 2000
XIA SPINE SYSTEM
K002505
Howmedica Osteonics Corp.
Orthopedic · 51d
Cleared Sep 12, 2000
USS VAS
K002517
Synthes (Usa)
Orthopedic · 28d