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 Sep 06, 2006
SYNTHES OC FUSION SYSTEM
K053418
Synthes Spine Co.Lp
Orthopedic · 272d
Cleared Aug 11, 2006
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K061579
Medtronic Sofamor Danek
Orthopedic · 65d
Cleared May 23, 2006
DENALI DEFORMITY SYSTEM
K052404
K2m, LLC
Orthopedic · 264d
Cleared Apr 18, 2006
ENDIUS MINIT POSTERIOR CERVICAL AND UPPER THORACIC FIXATION SYSTEM
K060683
Endius, Inc.
Orthopedic · 34d
Cleared Mar 10, 2006
SINTEA BIOTECH PLS MULTI-AXIAL SCREWS, MODEL PLS.XX.T5.X
K060513
Sintea Biotech, Inc.
Orthopedic · 11d
Cleared Feb 13, 2006
BASIS SPINAL SYSTEM
K060081
Medtronic Sofamor Danek
Orthopedic · 34d
Cleared Nov 10, 2005
SOLANAS POSTERIOR STABILIZATION SYSTEM
K052201
Alphatec Spine, Inc.
Orthopedic · 90d
Cleared Oct 21, 2005
MODIFICATION TO: VERTEX RECONSTRUCTION SYSTEM
K052734
Medtronic Sofamor Danek
Orthopedic · 21d
Cleared Sep 28, 2005
EXPEDIUM SPINE SYSTEM 5.5MM COMMERICALLY PURE TITANIUM SPINAL RODS
K052131
Depuy Spine, Inc.
Orthopedic · 54d
Cleared Sep 23, 2005
SYNTHES PANGEA SYSTEM
K052123
Synthes (Usa)
Orthopedic · 49d
Cleared Sep 23, 2005
MODIFICATION TO: VERTEX RECONSTRUCTION SYSTEM
K052376
Medtronic Sofamor Danek
Orthopedic · 24d
Cleared Sep 23, 2005
VERTEX RECONSTRUCTION SYSTEM
K052402
Medtronic Sofamor Danek
Orthopedic · 22d
Cleared Sep 14, 2005
NEX-LINK SPINAL FIXATION SYSTEM VARIABLE CROSSLINK, MODEL 721-XX
K052247
Abbott Spine, Inc.
Orthopedic · 27d
Cleared Sep 08, 2005
MODIFICATION TO XIA SPINAL SYSTEM
K052181
Stryker Spine
Orthopedic · 29d
Cleared Sep 07, 2005
VERTEBRON PSS PEDICLE SCREW SYSTEM
K051716
Vertebron, Inc.
Orthopedic · 72d
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 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