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
121–144 of 430
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 27, 2005
MALIBU SPINAL SYSTEM
K051942
Seaspine, Inc.
Orthopedic · 12d
Cleared Jul 21, 2005
PROTEX CT CERVICOTHORACIC SPINAL SYSTEM
K050391
Globus Medical, Inc.
Orthopedic · 155d
Cleared Jun 22, 2005
ZODIAC SPINAL FIXATION SYSTEM
K050830
Alphatec/Nexmed
Orthopedic · 82d
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 14, 2005
ISSYS PEDICLE SCREW SYSTEM
K043522
Custom Spine, Inc.
Orthopedic · 25d
Cleared Jan 12, 2005
MODIFICATION TO XIA SPINAL SYSTEM
K043473
Stryker Spine
Orthopedic · 27d
Cleared Jan 10, 2005
DENALI SPINE SYSTEM
K042635
K2m, LLC
Orthopedic · 105d
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 Dec 17, 2004
SINTEA BIOTECH POSTERIOR LUMBAR SYSTEM WITH POLYAXIAL AND RECOVERY SCREWS, MODEL PLS.01.T5.X
K043355
Sintea Biotech, Inc.
Orthopedic · 11d
Cleared Oct 27, 2004
ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM
K042673
Alphatec/Nexmed
Orthopedic · 28d
Cleared Oct 08, 2004
MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM
K042524
Medtronic Sofamor Danek
Orthopedic · 21d
Cleared Oct 07, 2004
EXCELLA-M SPINAL SYSTEM
K042143
Innovasis, Inc.
Orthopedic · 59d
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
ENDIUS TITLE 2 POLYAXIAL SPINAL SYSTEM
K041808
Endius, Inc.
Orthopedic · 87d
Cleared Oct 01, 2004
MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM
K042402
Medtronic Sofamor Danek, Inc.
Orthopedic · 28d