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
361–384 of 430
Cleared Mar 23, 1992
CROSSLINK SYSTEM
K911663
Synthes (Usa)
Orthopedic · 346d
Cleared Jan 22, 1992
TSRH VARIABLE ANGLE SACRAL SCREW
K904243
Danek Medical, Inc.
Orthopedic · 495d
Cleared Jan 16, 1992
LUQUE SEGMENTAL SPINAL INSTRUMENTATION
K913561
Zimmer, Inc.
Orthopedic · 160d
Cleared Dec 18, 1991
EDWARDS ANATO HOOK/UNIV ROD/WASH/SACR SCREW/ADJ CO
K914269
Scientific Spinal , Ltd.
Orthopedic · 85d
Cleared Oct 25, 1991
RAY SACRAL FIXATION SYSTEM
K904520
Danek Medical, Inc.
Orthopedic · 387d
Cleared Oct 24, 1991
CROSSLINK PLATE
K911307
Danek Medical, Inc.
Orthopedic · 213d
Cleared Sep 11, 1991
DANEK SACRAL HOOK, MODIFICATION
K911379
Danek Medical, Inc.
Orthopedic · 168d
Cleared Sep 06, 1991
TSRH OPEN HEAD BONE SCREW
K911319
Danek Medical, Inc.
Orthopedic · 164d
Cleared Jun 28, 1991
ISOLA(TM) SPINE SYSTEM - ILIAC SCREW
K911528
Acromed Corp.
Orthopedic · 85d
Cleared Jun 21, 1991
ISOLA(TM) SPINE SYSTEM--EYE ROD
K911394
Acromed Corp.
Orthopedic · 84d
Cleared Mar 21, 1991
ISOLA SLOTTED CONNECT/ANGLED SLOTTED CONNECTOR
K905826
Acromed Corp.
Orthopedic · 80d
Cleared Feb 15, 1991
ISOLA(TM) SPINE SYSTEM TOP ENTRY HOOK
K905184
Acromed Corp.
Orthopedic · 88d
Cleared Dec 27, 1990
ACROMED SACRAL SCREW
K903376
Acromed Corp.
Orthopedic · 150d
Cleared Dec 10, 1990
TSRH SPINAL SYSTEM (ADD'L SIZES OF HOOKS)
K901005
Danek Medical, Inc.
Orthopedic · 283d
Cleared Dec 10, 1990
KNIGHT SACRAL SCREW
K902775
Danek Medical, Inc.
Orthopedic · 168d
Cleared Dec 05, 1990
TSRH OFFSET AND SIDE-LOADING HOOKS
K903461
Danek Medical, Inc.
Orthopedic · 126d
Cleared Nov 05, 1990
TSRH SACRAL L-CONNECTOR
K901587
Danek Medical, Inc.
Orthopedic · 215d
Cleared Nov 05, 1990
MODULOCK POSTERIOR SPINAL FIXATION
K902397
Zimmer, Inc.
Orthopedic · 159d
Cleared Aug 21, 1990
DANEK SACRAL HOOK
K901590
Danek Medical, Inc.
Orthopedic · 138d
Cleared Aug 09, 1990
CHIBA SPINAL SYSTEM
K895978
Danek Medical, Inc.
Orthopedic · 301d
Cleared Jun 25, 1990
ROGOZINSKI SPINAL SYSTEM, ADD'L COMPONENTS
K896106
Richards Medical Co., Inc.
Orthopedic · 248d
Cleared Jun 14, 1990
DANEK PRECISION ROD SET
K896254
Danek Medical, Inc.
Orthopedic · 227d
Cleared Mar 20, 1990
SELBY II INSTRUMENTATION
K895296
Advanced Spine Fixation
Orthopedic · 207d
Cleared Feb 26, 1990
AXIAL AND OFFSET CROSSLINK PLATES
K896740
Danek Medical, Inc.
Orthopedic · 88d