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
409–430 of 430
Cleared Jul 21, 1987
HSC UNIT ROD
K871870
Research Development Corp.
Orthopedic · 69d
Cleared Jun 30, 1987
ANTERIOR SPINAL FIXATION PLATE
K870085
Terray Manufacturing, Inc.
Orthopedic · 173d
Cleared May 04, 1987
WARSAW ORTHOPEDIC TSR CROSS LINK SYSTEM
K870830
Warsaw Orthopedic, Inc.
Orthopedic · 62d
Cleared Feb 11, 1986
MARTIN LAMINAR OSTEOSYNTHESIS SYSTEM
K854770
Advanced Biosearch Assn.
Orthopedic · 76d
Cleared Dec 09, 1985
KIRSCHNER SPINAL PRODUCT SYSTEM
K854524
Kirschner Medical Corp.
Orthopedic · 27d
Cleared Nov 15, 1985
SONGER TITANIUM SPINE-L-ROD
K854313
Ortho-Engineering Products Co.
Orthopedic · 18d
Cleared Jun 07, 1985
EDWARDS SACRAL SCREW
K851935
Zimmer, Inc.
Orthopedic · 32d
Cleared May 29, 1985
HALIFAX SPINAL CLAMP
K850039
Levtech, Inc.
Orthopedic · 142d
Cleared Feb 13, 1985
SACRAL BAR
K843445
Stuart
Orthopedic · 161d
Cleared Jan 10, 1985
ROD FOR RACHIS SURGERY
K843687
Sofamor Co.
Orthopedic · 114d
Cleared Mar 23, 1984
HARRINGTON-TYPE INSTRU-SCOLIOSIS
K840423
Link America, Inc.
Orthopedic · 52d
Cleared Mar 19, 1982
A HOOK DRIVER
K820660
Twin City Surgical, Inc.
Orthopedic · 9d
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
Cleared Sep 27, 1978
HARRINGTON SPINE INSTRUMENTATION
K781443
Orthopedic Equipment Co., Inc.
Orthopedic · 35d
Cleared Sep 27, 1978
OUTRIGGER DISTRACTION UNIT
K781444
Orthopedic Equipment Co., Inc.
Orthopedic · 35d