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 Oct 01, 1996
COTREL-DUBOUSSET (CD) SPINAL
K955807
Sofamor Danek USA,Inc.
Orthopedic · 284d
Cleared Mar 27, 1996
COMPACT COTREL-DUBOUSSET (CCD) SPINAL SYSTEM
K955365
Sofamor Danek USA,Inc.
Orthopedic · 126d
Cleared Mar 11, 1996
ROGOZINSKI THORACOLUMBAR SPINAL ROD
K954696
Smith & Nephew Richards, Inc.
Orthopedic · 151d
Cleared Feb 16, 1996
TITANIUM MOSS MIAMI SPINAL SYSTEM
K955348
Depuy, Inc.
Orthopedic · 87d
Cleared Feb 09, 1996
CD LIBERTY POSTERIOR SPINCAL SYSTEM
K951164
Sofamor Danek USA,Inc.
Orthopedic · 332d
Cleared Jan 16, 1996
TITANIUM GDLH POSTERIOR SPINAL SYSTEM
K954645
Sofamor Danek USA,Inc.
Orthopedic · 98d
Cleared Sep 01, 1994
STRYKER 2S SPINAL SYSTEM
K930009
Stryker Corp.
Orthopedic · 605d
Cleared Jul 12, 1994
DEPUY MOTECH MOSS-MIAMI SPINAL SYSTEM
K933881
Depuy, Inc.
Orthopedic · 336d
Cleared Jun 03, 1994
TI-FRAME
K934860
Johnson & Johnson Professionals, Inc.
Orthopedic · 234d
Cleared May 04, 1994
TSRH(R) TOP TIGHT T-BOLT-VARI ANGLE/SCREW/PARAGON
K933205
Danek Medical, Inc.
Orthopedic · 307d
Cleared Apr 29, 1994
SYNTHES (USA) UNIV SPINE ROD/SACRAL SCREW FIX SYST
K930891
Synthes (Usa)
Orthopedic · 431d
Cleared Jun 24, 1993
COTREL - DUBOUSSET SPINE IMPLANTS
K921056
Buckman Co., Inc.
Orthopedic · 476d
Cleared Jun 22, 1993
COMPACT COTREL -- DUBOUSSET SPINE SYSTEM
K921767
Buckman Co., Inc.
Orthopedic · 434d
Cleared Jun 22, 1993
SYNTHES UNIVERSAL SPINE HOOK AND ROD FIXATION SYST
K921948
Synthes (Usa)
Orthopedic · 421d
Cleared Jun 15, 1993
CODMAN(TM) TITANIUM INTERLAMINAR CLAMP KIT
K924142
Codman & Shurtleff, Inc.
Orthopedic · 302d
Cleared May 18, 1993
ISOLA(R) TANDEM CONNECTOR
K922504
Acromed Corp.
Orthopedic · 356d
Cleared Dec 31, 1992
ISOLA SPINE SYSTEM: PLATE-ROD COMBINATION
K920392
Acromed Corp.
Orthopedic · 336d
Cleared Dec 31, 1992
ISOLA(R) TRANSVERSE ROD DUAL CONNECTOR
K921090
Acromed Corp.
Orthopedic · 300d
Cleared Aug 26, 1992
MCAFEE SPINAL SYSTEM FOR POSTERIOR APPLICATIONS
K912837
Kirschner Medical Corp.
Orthopedic · 427d
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 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