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
169–192 of 303
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 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 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 Jul 24, 2002
MODIFICATION TO SUMMIT OCCIPITO-CERVICO-THORACIC (OCT) SPINAL SYSTEM
K022190
Depuyacromed
Orthopedic · 19d
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
Cleared Feb 01, 2002
BLACKSTONE SPINAL FIXATION SYSTEM POSTERIOR HOOKS
K013885
Blackstone Medical, Inc.
Orthopedic · 70d
Cleared Nov 15, 2001
PASS SPINAL SYSTEM
K013431
Encore Orthopedics, Inc.
Orthopedic · 30d
Cleared Nov 14, 2001
TRI-FIX SPINAL FIXATION SYSTEM
K013403
Endius, Inc.
Orthopedic · 30d
Cleared Nov 07, 2001
SUMMIT OCCIPITO-CERVICO- THORACIC (OCT) SPINAL SYSTEM
K013222
Depuyacromed
Orthopedic · 41d
Cleared Oct 24, 2001
PASS SPINAL SYSTEM
K013191
Encore Orthopedics, Inc.
Orthopedic · 30d
Cleared Aug 07, 2001
SCS CLARIS SPINAL SCREWS, TYPES V,G,E
K011807
Ortho Tec, LLC
Orthopedic · 57d
Cleared Jul 31, 2001
PASS SPINAL SYSTEM
K012175
Encore Orthopedics, Inc.
Orthopedic · 19d
Cleared Jun 12, 2001
ISOLA BAND CLAMP
K010972
Depuyacromed
Orthopedic · 71d
Cleared Jun 06, 2001
TRI-FIX SPINAL FIXATION SYSTEM
K010903
Endius, Inc.
Orthopedic · 72d
Cleared Jun 06, 2001
TRI-FIX SPINAL FIXATION SYSTEM
K010922
Endius, Inc.
Orthopedic · 71d