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 Nov 22, 2002
MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM
K023555
Medtronic Sofamor Danek, Inc.
Orthopedic · 30d
Cleared Nov 19, 2002
ORIA SPINAL CLIP SYSTEM
K021679
Ortho Tec, LLC
Orthopedic · 182d
Cleared Nov 13, 2002
MODIFICATION TO BLACKSTONE SPINAL FIXATION SYSTEM
K023498
Blackstone Medical, Inc.
Orthopedic · 26d
Cleared Sep 24, 2002
CADENCE SPINAL FIXATION SYSTEM
K022374
Sulzer Spine-Tech
Orthopedic · 64d
Cleared Aug 28, 2002
MODIFICATION TO TENOR SPINAL SYSTEM
K022191
Medtronic Sofamor Danek, Inc.
Orthopedic · 54d
Cleared Aug 27, 2002
5.0 MM DIAMETER POLYAXIAL SCREWS (MOSS MIAMI 6.35MM SYSTEM)
K022623
Depuyacromed
Orthopedic · 20d
Cleared Aug 01, 2002
PLUS PIVOT LINK UNIVERSAL SYSTEM
K021507
Spine Vision, Inc.
Orthopedic · 84d
Cleared Jul 25, 2002
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K021061
Medtronic Sofamor Danek
Orthopedic · 114d
Cleared Jul 22, 2002
XANTUS ANTERIOR LATERAL SUPPLEMENTAL FIXATION SYSTEM
K022070
Medtronic Sofamor Danek, Inc.
Orthopedic · 26d
Cleared Jul 18, 2002
MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM
K022015
Medtronic Sofamor Danek, Inc.
Orthopedic · 28d
Cleared Jul 09, 2002
TSRH SPINAL SYSTEM
K021170
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 88d
Cleared Jul 03, 2002
SCS CLARIS SPINAL SYSTEM,REXTENDED OMNIAXIAL CONNECTOR-,MEDIUM, MODEL CO05, SCS CLARIS SPINAL SYSTEM,EXTENDED OMNIAXIALO
K021919
Ortho Tec, LLC
Orthopedic · 22d
Cleared Jul 01, 2002
MODIFICATION TO SPIRAL RADIUS 90-D SST SYSTEM
K021825
Unitedstates Surgical
Orthopedic · 27d
Cleared Jun 18, 2002
OCTAFIX OCCIPITAL CERVICAL PLATING SYSTEM
K021009
Spinal Concepts, Inc.
Orthopedic · 82d
Cleared May 09, 2002
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K020709
Medtronic Sofamor Danek
Orthopedic · 65d
Cleared Apr 15, 2002
SPIRAL RADIUS 90-D RODDING SYSTEM
K020134
United States Surgical, A Division of Tyco Healthc
Orthopedic · 90d
Cleared Mar 11, 2002
ENDIUS SPINAL FIXATION SYSTEM
K014090
Endius, Inc.
Orthopedic · 90d
Cleared Feb 26, 2002
MSD WIRE SYSTEM
K020426
Medtronic Sofamor Danek, Inc.
Orthopedic · 18d
Cleared Feb 14, 2002
MODIFICATION TO PASS SPINAL SYSTEM
K020236
Encore Orthopedics, Inc.
Orthopedic · 22d
Cleared Feb 13, 2002
P.L.U.S. SYSTEM (PIVOT LINK UNIVERSAL SYSTEM)
K013312
Spine Vision, Inc.
Orthopedic · 132d
Cleared Feb 05, 2002
DYNA-LOK CLASSIC SPINAL SYSTEM
K020155
Medtronic Sofamor Danek
Orthopedic · 19d
Cleared Jan 30, 2002
ASCEND SPINAL FIXATION SYSTEM WITH THE SHADOW SPINAL SYSTEM
K013196
Spinal Innovations, LLC
Orthopedic · 127d
Cleared Jan 25, 2002
BUTTERFLY PLATE FIXATION SYSTEM
K014267
Medtronic Sofamor Danek, Inc.
Orthopedic · 29d
Cleared Jan 15, 2002
PASS SPINAL SYSTEM
K013442
Encore Orthopedics, Inc.
Orthopedic · 90d