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 Medtronic Sofamor Danek.

303
Total
303
Cleared
95d
Avg days
1998
Since
303 devices
217–240 of 303
Cleared Jul 30, 2003
UCR SPINAL SYSTEM, LAMINAR HOOKS, PEDICLE HOOKS, AND INSTRUMENTS
K031381
Seaspine
Orthopedic · 90d
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
Cleared Mar 12, 2003
OPTIMA, SPINAL SYSTEM
K024096
U&I Corp., America
Orthopedic · 90d
Cleared Mar 06, 2003
MODIFICATION TO SYNTHES CERVIFIX SYSTEM
K030377
Synthes (Usa)
Orthopedic · 29d
Cleared Feb 05, 2003
SUMMIT OCT SPINAL SYSTEM MINIPOLYAXIAL SCREWS
K030103
Depuyacromed
Orthopedic · 23d
Cleared Dec 11, 2002
ALPHA MIRAGE TOP TIGHTENING SPINAL SYSTEM
K023299
Alphatec Mfg., Inc.
Orthopedic · 69d
Cleared Nov 25, 2002
MODIFICATION TO INCOMPASS SPINAL FIXATION SYSTEM
K023644
Spinal Concepts, Inc.
Orthopedic · 26d
Cleared Nov 13, 2002
AMT POLYAXIAL PEDICLE SCREW
K022768
Micron Precision Engineering, Inc.
Orthopedic · 84d
Cleared Sep 23, 2002
PLUS PIVOT LINK UNIVERSAL SYSTEM
K022271
Spine Vision, Inc.
Orthopedic · 72d
Cleared Sep 18, 2002
MODIFICATION TO TSRH SPINAL SYSTEM
K022778
Medtronic Sofamor Danek, Inc.
Orthopedic · 27d
Cleared Aug 13, 2002
MODIFICATION TO ISOLA SPINAL SYSTEM
K022285
Depuyacromed
Orthopedic · 29d
Cleared Aug 01, 2002
UNI-T UNI-THREAD SPINAL SYSTEM
K021510
Spine Vision, Inc.
Orthopedic · 84d
Cleared Aug 01, 2002
XIA SPINAL SYSTEM
K022160
Howmedica Osteonics
Orthopedic · 29d
Cleared Jul 24, 2002
MODIFICATION TO SUMMIT OCCIPITO-CERVICO-THORACIC (OCT) SPINAL SYSTEM
K022190
Depuyacromed
Orthopedic · 19d
Cleared Jul 18, 2002
MICOMED POSTERIOR DOUBLEROD SYSTEM
K021275
Micomed Ortho GmbH
Orthopedic · 87d
Cleared Jun 20, 2002
FOREX CORPORATION, OPTIMA, SPINAL SYSTEM
K020279
Forex Corp.
Orthopedic · 143d
Cleared May 31, 2002
SCS CLARIS SPINAL SYSTEM, LENGTHENED LATERAL CONNECTOR, MODEL AL06
K021379
Ortho Tec, LLC
Orthopedic · 30d
Cleared May 03, 2002
MODIFICATION TO TSRH SPINAL SYSTEM
K021106
Medtronic Sofamor Danek, Inc.
Orthopedic · 28d
Cleared Apr 15, 2002
SYNTHES DUAL-OPENING USS
K020517
Synthes (Usa)
Orthopedic · 55d