KWP · Class II · 21 CFR 888.3050

FDA Product Code KWP: Appliance, Fixation, Spinal Interlaminal

Leading manufacturers include Synthes (Usa), Depuy, Inc. and Howmedica Osteonics Corp..

430
Total
430
Cleared
130d
Avg days
1978
Since
430 devices
25–48 of 430
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 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 Mar 26, 1997
DEPUY MOTECH TITANIUM MOSS MIAMI SPINAL SYSTEM
K964024
Depuy, Inc.
Orthopedic · 170d
Cleared Mar 18, 1997
MOSS MIAMI SPINAL SYSTEM
K962628
Depuy, Inc.
Orthopedic · 256d
Cleared Mar 13, 1997
DEPUY MOTECH MOSS MIAMI SPINAL SYSTEM
K965145
Depuy, Inc.
Orthopedic · 80d
Cleared Feb 16, 1996
TITANIUM MOSS MIAMI SPINAL SYSTEM
K955348
Depuy, Inc.
Orthopedic · 87d
Cleared Jul 12, 1994
DEPUY MOTECH MOSS-MIAMI SPINAL SYSTEM
K933881
Depuy, Inc.
Orthopedic · 336d
Cleared Apr 29, 1994
SYNTHES (USA) UNIV SPINE ROD/SACRAL SCREW FIX SYST
K930891
Synthes (Usa)
Orthopedic · 431d
Cleared Jun 22, 1993
SYNTHES UNIVERSAL SPINE HOOK AND ROD FIXATION SYST
K921948
Synthes (Usa)
Orthopedic · 421d
Cleared Mar 23, 1992
CROSSLINK SYSTEM
K911663
Synthes (Usa)
Orthopedic · 346d
Cleared Jan 16, 1992
LUQUE SEGMENTAL SPINAL INSTRUMENTATION
K913561
Zimmer, Inc.
Orthopedic · 160d
Cleared Nov 05, 1990
MODULOCK POSTERIOR SPINAL FIXATION
K902397
Zimmer, Inc.
Orthopedic · 159d
Cleared Feb 24, 1989
MODULAR SPINAL FIXATION & LOCKING HOOK SPINAL ROD
K884688
Synthes (Usa)
Orthopedic · 108d
Cleared Jun 07, 1985
EDWARDS SACRAL SCREW
K851935
Zimmer, Inc.
Orthopedic · 32d
Cleared Apr 08, 1981
DEPUY SEGMENTALSPINAL SYSTEM
K810329
Depuy, Inc.
Orthopedic · 58d
Cleared Feb 10, 1981
ARMSTRONG SPINAL APPLIANCE
K810224
Howmedica Corp.
Orthopedic · 14d
Cleared Dec 16, 1980
SYNTHES SPINAL IMPLANT SYSTEM
K802462
Synthes (Usa)
Orthopedic · 69d
Cleared May 20, 1980
EDWARDS ROD SLEEVES
K801080
Zimmer, Inc.
Orthopedic · 13d
Cleared May 20, 1980
DUNN ANTERIOR DISTRACTION SYSTEM
K801120
Zimmer, Inc.
Orthopedic · 8d
Cleared Jun 11, 1979
SANTA CASA DISTRACTOR
K791009
Depuy, Inc.
Orthopedic · 11d
Cleared Apr 12, 1979
KNEE COMPRESSION HOOK SYSTEM
K790465
Zimmer, Inc.
Orthopedic · 38d
Cleared Feb 12, 1979
TRANSVERSE TRACTION ASSEMBLY
K790238
Zimmer, Inc.
Orthopedic · 11d