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
289–312 of 430
Cleared Dec 19, 1995
SENTRY(TM) ANTERIOR/POSTERIOR SPINAL SYSTEMS
K936294
Sofamor Danek Mfg., Inc.
Orthopedic · 739d
Cleared Jun 22, 1995
WEBB-MORLEY SPINE SYSTEM
K945781
Electro-Biology, Inc.
Orthopedic · 209d
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 29, 1994
ALPHA SPINAL SYSTEM
K930515
Alphatec Mfg., Inc.
Orthopedic · 513d
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 May 02, 1994
LOW PROFILE MID CROSS BRACING
K931225
Advanced Spine Fixation Systems, Inc.
Orthopedic · 418d
Cleared Apr 29, 1994
SYNTHES (USA) UNIV SPINE ROD/SACRAL SCREW FIX SYST
K930891
Synthes (Usa)
Orthopedic · 431d
Cleared Mar 28, 1994
LOW PROFILE SLEAVE NUT ASSEMBLY
K931208
Advanced Spine Fixation Systems, Inc.
Orthopedic · 383d
Cleared Oct 01, 1993
SENTRY POSTERIOR SPINAL SYSTEM
K930710
Sofamor Danek Mfg., Inc.
Orthopedic · 232d
Cleared Sep 21, 1993
SELBY INSTRUMENTATION
K924474
Advanced Spine Fixation Systems, Inc.
Orthopedic · 383d
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
LUQUE V SPINAL SYSTEM
K921256
Sofamor Danek Mfg., Inc.
Orthopedic · 428d
Cleared May 18, 1993
ISOLA(R) TANDEM CONNECTOR
K922504
Acromed Corp.
Orthopedic · 356d
Cleared May 18, 1993
AUGMENT POSTERIOR SPINAL FIXATION SYSTEM
K922672
Sofamor Danek Mfg., Inc.
Orthopedic · 348d
Cleared May 18, 1993
TSRH CENTRAL POST HOOKS
K925811
Sofamor Danek Mfg., Inc.
Orthopedic · 285d
Cleared Jan 21, 1993
PARAGON POSTERIOR SPINAL SYSTEM
K920546
Sofamor Danek Mfg., Inc.
Orthopedic · 350d
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 Nov 16, 1992
MODIFIED TSRH CENTRAL POST HOOKS
K922520
Sofamor Danek Mfg., Inc.
Orthopedic · 178d