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
337–360 of 430
Cleared Jun 14, 1990
DANEK PRECISION ROD SET
K896254
Danek Medical, Inc.
Orthopedic · 227d
Cleared Feb 26, 1990
AXIAL AND OFFSET CROSSLINK PLATES
K896740
Danek Medical, Inc.
Orthopedic · 88d
Cleared Jan 30, 1990
HSC UNIT ROD
K896603
Danek Medical, Inc.
Orthopedic · 70d
Cleared Jan 04, 1990
LUQUE III SPINAL SYSTEM AND LUQUE MINI-SET
K890192
Danek Medical, Inc.
Orthopedic · 351d
Cleared Nov 22, 1989
ACROMED DOUBLE SUBLAMINAR WIRE
K895413
Acromed Corp.
Orthopedic · 78d
Cleared Nov 22, 1989
ACROMED BEADED SUBLAMINAR WIRE
K895439
Acromed Corp.
Orthopedic · 78d
Cleared Nov 22, 1989
ACROMED BUTTON SPINAL WIRE
K895441
Acromed Corp.
Orthopedic · 78d
Cleared Oct 10, 1989
CROSS ROUND & SQUARE SPINAL RODS & DIST. SPINAL
K894472
Buckman Co., Inc.
Orthopedic · 84d
Cleared Jun 02, 1989
KIRSCHNER SPINAL FIXATOR KMS-1
K884690
Kirschner Medical Corp.
Orthopedic · 205d
Cleared May 03, 1989
ACROMED ILIAC SCREW
K884161
Buckman Co., Inc.
Orthopedic · 211d
Cleared Apr 26, 1989
ACROMED SPINAL ROD AND SPINAL HOOKS
K884163
Buckman Co., Inc.
Orthopedic · 204d
Cleared Apr 06, 1989
TSRH SACRAL SPINAL SCREW
K883783
Warsaw Orthopedic, Inc.
Orthopedic · 212d
Cleared Apr 06, 1989
THE C-S DISTRACTION ROD ASSEMBLY
K890187
Orthopedic Systems, Inc.
Orthopedic · 78d
Cleared Feb 24, 1989
MODULAR SPINAL FIXATION & LOCKING HOOK SPINAL ROD
K884688
Synthes (Usa)
Orthopedic · 108d
Cleared Jan 27, 1989
LEA PLAZA SPINAL FRAME SYSTEM
K884585
Orthomet, Inc.
Orthopedic · 86d
Cleared Dec 29, 1988
ROGOZINSKI SPINAL SYSTEM
K884263
Richards Medical Co., Inc.
Orthopedic · 79d
Cleared Jun 03, 1988
COBB SPINAL ELEVATORS
K882068
Karlin Technology, Inc.
Orthopedic · 17d
Cleared Jun 03, 1988
LUMBAR IMPACTION SET AND BONE GRAFT IMPACTORS
K882070
Karlin Technology, Inc.
Orthopedic · 17d
Cleared Mar 04, 1988
LUMBAR IMPACTION SET
K875290
T. Korossurgical Instruments Corp.
Orthopedic · 65d
Cleared Mar 04, 1988
TSRH H/M HOOK HOLDER
K880211
Warsaw Orthopedic, Inc.
Orthopedic · 45d
Cleared Mar 04, 1988
TSRH H/M HOOK HOLDER W/ROD MOVER
K880212
Warsaw Orthopedic, Inc.
Orthopedic · 45d
Cleared Feb 18, 1988
ACROMED CROSS ROD CONNECTOR
K874882
Acromed Corp.
Orthopedic · 79d
Cleared Feb 18, 1988
TSRH H/M TORQUE LIMITING WRENCH
K880214
Warsaw Orthopedic, Inc.
Orthopedic · 30d
Cleared Feb 18, 1988
TSRH H/M HOOK, EYEBOLT/LOCK NUT ASSEM., SPINAL ROD
K880215
Warsaw Orthopedic, Inc.
Orthopedic · 30d