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
97–120 of 303
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 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 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 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 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
SYNERGY 4.0 MM, 4.5 MM VLS SCREWS
K011437
Interpore Cross Intl.
Orthopedic · 27d
Cleared Jun 05, 2001
MODIFICATION TO TSRH SPINAL SYSTEM
K011029
Medtronic Sofamor Danek, Inc.
Orthopedic · 61d
Cleared Jun 04, 2001
MODIFIED USS FRACTURE SYSTEM
K010658
Synthes (Usa)
Orthopedic · 90d
Cleared May 23, 2001
MONARCH SPINE SYSTEM
K010576
Depuyacromed
Orthopedic · 85d
Cleared May 08, 2001
BLACKSTONE SPINAL FIXATION SYSTEM, SECOND-GENERATION CROSS-CONNECTOR
K003735
Blackstone Medical, Inc.
Orthopedic · 155d
Cleared May 04, 2001
MODIFICATION TO TSRH SPINAL SYSTEM
K011067
Medtronic Sofamor Danek, Inc.
Orthopedic · 25d
Cleared Oct 17, 2000
SMALL STATURE USS
K994121
Synthes (Usa)
Orthopedic · 316d
Cleared May 11, 2000
MULTI-AXIAL CROSS (MAC) CONNECTOR
K000965
Howmedica Osteonics Corp.
Orthopedic · 45d
Cleared Apr 18, 2000
SYNERGY ADJUSTABLE TRANSVERSE CONNECTOR ROD, SYNERGY ADJUSTABLE TRANSVERSE CONNECTOR LAMP
K000876
Interpore Cross Intl.
Orthopedic · 29d
Cleared Apr 18, 2000
MODIFICATION TO TSRH SPINAL SYSTEM
K000991
Medtronic Sofamor Danek, Inc.
Orthopedic · 21d
Cleared Apr 14, 2000
MODIFICATION TO EBI SPINELINK SYSTEM
K001037
Ebi, L.P.
Orthopedic · 14d