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
241–264 of 430
Cleared Dec 18, 1998
SCS SPINAL SYSTEM
K983353
Orthotec, Inc.
Orthopedic · 86d
Cleared Dec 16, 1998
SYNTHES POSTERIOR UNIVERSAL SPINAL SYSTEM
K983530
Synthes (Usa)
Orthopedic · 69d
Cleared Dec 03, 1998
DEPUY ACROMED MOSS AND MOSS MIAMI SPINAL SYSTEMS
K983583
Depuy, Inc.
Orthopedic · 51d
Cleared Nov 25, 1998
SYNTHES SPINE OCCIPITAL-CERVICAL PLATE/ROD AND HOOK SYSTEM
K982322
Synthes (Usa)
Orthopedic · 146d
Cleared Nov 19, 1998
OMI OCCIPITAL CERVICAL LOOP, MODEL A1089
K983282
Ohio Medical Instrument Co., Inc.
Orthopedic · 62d
Cleared Nov 12, 1998
MODIFICATION OF TOWNLEY PEDICLE SCREW PLATING SYSTEM
K983706
Sofamor Danek USA,Inc.
Orthopedic · 22d
Cleared Oct 26, 1998
SURGICAL DYNAMICS RODDING SYSTEM (PREVIOUSLY KNOWN AS THE AURORA TITANIUM SPINAL ROD SYSTEM)
K983197
United States Surgical, A Division of Tyco Healthc
Orthopedic · 45d
Cleared Oct 05, 1998
TENOR SPINAL SYSTEM
K982490
Sofamor Danek USA,Inc.
Orthopedic · 80d
Cleared Sep 14, 1998
DEPUY MOTECH MOSS MIAMI SPINAL SYSTEM
K982320
Depuy, Inc.
Orthopedic · 74d
Cleared Sep 14, 1998
DEPUY MOTECH MOSS MIAMI SPINAL SYSTEMS
K982511
Depuy, Inc.
Orthopedic · 56d
Cleared Sep 08, 1998
BWM SPINE SYSTEM
K982494
Howmedica Corp.
Orthopedic · 53d
Cleared Aug 28, 1998
MODIFICATION TO EBI SPINELINK SYSTEM
K982908
Electro-Biology, Inc.
Orthopedic · 10d
Cleared Aug 06, 1998
DEPUY MOTECH MOSS MIAMI SPINAL SYSTEM
K982011
DePuy Orthopaedics, Inc.
Orthopedic · 59d
Cleared Jul 29, 1998
SPINE-TECH SILHOUETTE SPINAL FIXATION SYSTEM
K980288
Spine-Tech, Inc.
Orthopedic · 184d
Cleared Jun 10, 1998
AESCULAP SPINE SYSTEM ADDITIONAL COMPONENTS
K980121
Aesculap, Inc.
Orthopedic · 147d
Cleared May 20, 1998
OSTEONICS LONG ARM CONTAINMENT RING
K981452
Osteonics Corp.
Orthopedic · 28d
Cleared May 11, 1998
SYNTHES SPINE UNIVERSAL SPINAL HOOK, ROD, PEDICLE/SACRAL SCREW FIXATION SYSTEM
K980928
Synthes Spine
Orthopedic · 61d
Cleared Apr 16, 1998
SYNTHES SPINE POSTERIOR CERVICAL/THORACIC HOOK/ROD SYSTEM
K980358
Synthes (Usa)
Orthopedic · 77d
Cleared Feb 18, 1998
DEPUY MOTECH MOSS-MIAMI SPINAL SYSTEM
K974573
Depuy, Inc.
Orthopedic · 72d
Cleared Jan 08, 1998
SSCS (SEGMENTAL SPINAL CORRECTION SYSTEM)
K973868
Osteotech, Inc.
Orthopedic · 90d
Cleared Oct 16, 1997
CD SPINAL SYSTEM
K964159
Sofamor Danek USA,Inc.
Orthopedic · 365d
Cleared Aug 07, 1997
RANSFORD CERVICAL FIXATION SYSTEM
K965221
Surgicraft , Ltd.
Orthopedic · 219d
Cleared Jul 16, 1997
BRYAN POSTERIOR SPINAL FIXATOR (BPSF), MODIFIED
K971457
Arcan Orthopaedic Corp.
Orthopedic · 110d
Cleared Jun 18, 1997
SSCS (SEGMENTAL SPINAL CORRECTION SYSTEM)
K971289
Osteotech, Inc.
Orthopedic · 72d