MNI · Class II · 21 CFR 888.3070

FDA Product Code MNI: Orthosis, Spinal Pedicle Fixation

Leading manufacturers include K2m, Inc., Medtronic Sofamor Danek, Inc. and Spine Wave, Inc..

303
Total
303
Cleared
95d
Avg days
1998
Since
303 devices
73–96 of 303
Cleared Oct 07, 2004
MODIFICATION TO EQUATION FIXATION SYSTEM
K042453
Medtronic Sofamor Danek, Inc.
Orthopedic · 27d
Cleared Oct 07, 2004
MODIFICATION TO BLACKSTONE MODULAR PEDICLE SCREW SYSTEM
K042514
Blackstone Medical, Inc.
Orthopedic · 21d
Cleared Sep 20, 2004
BLACKSTONE ASCENT POCT SYSTEM 5.5MM/3.0MM SINGLE AXIAL CONNECTOR
K042100
Blackstone Medical, Inc.
Orthopedic · 47d
Cleared Sep 03, 2004
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K041777
Medtronic Sofamor Danek
Orthopedic · 64d
Cleared Jun 30, 2004
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K041030
Medtronic Sofamor Danek
Orthopedic · 70d
Cleared Jun 02, 2004
SUMMIT OCT SPINAL SYSTEM
K041203
Depuy Spine, Inc.
Orthopedic · 26d
Cleared May 28, 2004
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K041118
Medtronic Sofamor Danek
Orthopedic · 29d
Cleared Mar 31, 2004
MODIFICATION TO: CD HORIZON SPINAL SYSTEM
K040583
Medtronic Sofamor Danek
Orthopedic · 26d
Cleared Feb 20, 2004
STRYKER SPINE OASYS SYSTEM
K032394
Howmedica Osteonics Corp.
Orthopedic · 200d
Cleared Feb 11, 2004
BLACKSTONE ASCENT POCT SYSTEM LATERAL OFFSET ADAPTER
K040034
Blackstone Medical, Inc.
Orthopedic · 34d
Cleared Jan 22, 2004
POSTERIOR CABLE SCREW
K022908
Pioneer Surgical Technology
Orthopedic · 506d
Cleared Dec 03, 2003
MODIFICATION TO EQUATION FIXATION SYSTEM
K033495
Medtronic Sofamor Danek, Inc.
Orthopedic · 28d
Cleared Nov 06, 2003
DYNALOK CLASSIC SPINAL SYSTEM
K033271
Medtronic Sofamor Danek
Orthopedic · 27d
Cleared Sep 17, 2003
TSRH SPINAL SYSTEM
K031967
Medtronic Sofamor Danek, Inc.
Orthopedic · 83d
Cleared Sep 17, 2003
TSRH SPINAL SYSTEM
K032578
Medtronic Sofamor Danek, Inc.
Orthopedic · 27d
Cleared Sep 04, 2003
CD HORIZON (ADDITION OF SPINOUS PROCESS PLATE)
K032037
Medtronic Sofamor Danek
Orthopedic · 65d
Cleared Sep 03, 2003
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K031833
Medtronic Sofamor Danek
Orthopedic · 82d
Cleared Aug 06, 2003
EBI OMEGA21 SPINAL FIXATION SYSTEM
K031354
Ebi, L.P.
Orthopedic · 99d
Cleared Jun 27, 2003
CD HORIZON SPINAL SYSTEM
K031655
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 30d
Cleared Jun 27, 2003
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K031888
Medtronic Sofamor Danek
Orthopedic · 9d
Cleared May 16, 2003
CD HORIZON SPINAL SYSTEM
K030932
Medtronic Sofamor Danek, Inc.
Orthopedic · 52d
Cleared May 15, 2003
MODIFICATION TO HORIZON SPINAL SYSTEM
K030840
Medtronic Sofamor Danek, Inc.
Orthopedic · 59d
Cleared Apr 17, 2003
BLACKSTONE SPINAL FIXATION SYSTEM RIGID CROSS CONNECTOR
K030862
Blackstone Medical, Inc.
Orthopedic · 30d
Cleared Mar 24, 2003
SYNTHES USS, CLICK'X, USS VAS, DUAL-OPENING USS AND SMALL STATURE USS
K022949
Synthes (Usa)
Orthopedic · 200d