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
73–96 of 430
Cleared Sep 23, 2005
VERTEX RECONSTRUCTION SYSTEM
K052402
Medtronic Sofamor Danek
Orthopedic · 22d
Cleared Sep 08, 2005
MODIFICATION TO XIA SPINAL SYSTEM
K052181
Stryker Spine
Orthopedic · 29d
Cleared Aug 23, 2005
MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM
K052180
Medtronic Sofamor Danek
Orthopedic · 13d
Cleared Aug 18, 2005
MODIFICATION TO: XIA STAINLESS STEEL SYSTEM
K051973
Stryker Spine
Orthopedic · 28d
Cleared Aug 17, 2005
PROTEX STABILIZATION SYSTEM WITH ADDITIONAL COMPONENTES
K052069
Globus Medical, Inc.
Orthopedic · 16d
Cleared Jul 21, 2005
PROTEX CT CERVICOTHORACIC SPINAL SYSTEM
K050391
Globus Medical, Inc.
Orthopedic · 155d
Cleared Jun 14, 2005
CD HORIZON SPINAL SYSTEM
K050809
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 75d
Cleared May 04, 2005
BASIS SPINAL SYSTEM
K050484
Medtronic Sofamor Danek, Inc.
Orthopedic · 68d
Cleared Apr 11, 2005
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K043053
Medtronic Sofamor Danek
Orthopedic · 157d
Cleared Feb 16, 2005
TECHTONIX SYSTEM
K050189
Stryker Spine
Orthopedic · 20d
Cleared Feb 10, 2005
CD HORIZON SPINAL SYSTEM
K050079
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 28d
Cleared Jan 12, 2005
MODIFICATION TO XIA SPINAL SYSTEM
K043473
Stryker Spine
Orthopedic · 27d
Cleared Jan 07, 2005
GLAXY 3.2 SPINAL SYSTEM
K043020
Medtronic Sofamor Danek
Orthopedic · 65d
Cleared Dec 21, 2004
VERTEX RECONSTRUCTION SYSTEM
K042789
Medtronic Sofamor Danek
Orthopedic · 76d
Cleared Dec 21, 2004
MODIFICATION TO ALTIUS OCT SYSTEM
K043229
Interpore Cross Intl.
Orthopedic · 29d
Cleared Oct 08, 2004
MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM
K042524
Medtronic Sofamor Danek
Orthopedic · 21d
Cleared Oct 07, 2004
VERTEX RECONSTRUCTION SYSTEM
K042498
Medtronic Sofamor Danek
Orthopedic · 23d
Cleared Oct 07, 2004
SUMIT OCT SPINAL SYSTEM AND MOUNTAINEER OCT SPINAL SYSTEM
K042508
Depuy Spine, Inc.
Orthopedic · 22d
Cleared Oct 01, 2004
MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM
K042402
Medtronic Sofamor Danek, Inc.
Orthopedic · 28d
Cleared Sep 24, 2004
ST360 SPINAL FIXATION SYSTEM
K041925
Zimmer Spine, Inc.
Orthopedic · 67d
Cleared Sep 15, 2004
CD HORIZON SPINAL SYSTEM
K041862
Medtronic Sofamor Danek
Orthopedic · 68d
Cleared Jul 19, 2004
EXPEDIUM SPINE SYSTEM
K041119
Depuy Spine, Inc.
Orthopedic · 81d
Cleared Jul 01, 2004
SYNERGY HELICAL FLANGE PLUG, HELICAL FLANGE SEAT AND HELICAL FLANGE REDUCTION SEAT
K041449
Interpore Cross Intl.
Orthopedic · 30d
Cleared Jun 10, 2004
MODIFICATION TO TSRH SPINAL SYSTEM
K041282
Medtronic Sofamor Danek, Inc.
Orthopedic · 28d