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
25–48 of 303
Cleared Jul 22, 2011
VENUS CERVICAL SPINAL FIXATION SYSTEM
K103414
L & K Biomed Co., Ltd.
Orthopedic · 242d
Cleared Jul 15, 2011
EXACTECH GIBRALT SPINAL SYSTEM
K110197
Exactech, Inc.
Orthopedic · 172d
Cleared Mar 17, 2011
EVEREST SPINAL SYSTEM
K103440
K2m, Inc.
Orthopedic · 114d
Cleared Nov 17, 2010
MOUNTAINEER OCT SPINAL SYSTEM
K103100
Depuy Spine, Inc.
Orthopedic · 28d
Cleared Nov 05, 2010
LIFE SPINE INTERSPINOUS FIXATION SYSTEM
K100407
Life Spine
Orthopedic · 262d
Cleared Aug 02, 2010
RANGE SPINAL SYSTEM
K100851
K2m, Inc.
Orthopedic · 129d
Cleared Mar 11, 2010
ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM
K093936
Spineart
Orthopedic · 79d
Cleared Feb 17, 2010
ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM
K100138
Alphatec Spine, Inc.
Orthopedic · 29d
Cleared Dec 23, 2009
ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM
K093077
Alphatec Spine, Inc.
Orthopedic · 84d
Cleared Nov 06, 2009
CASPIAN SPINAL SYSTEM
K092640
K2m, Inc.
Orthopedic · 71d
Cleared Nov 04, 2009
ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM
K093170
Spineart
Orthopedic · 28d
Cleared Jul 08, 2009
ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM
K091189
Alphatec Spine, Inc.
Orthopedic · 76d
Cleared Jul 07, 2009
ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM
K090779
Alphatec Spine, Inc.
Orthopedic · 106d
Cleared Jan 28, 2009
PILOT SPINAL SYSTEM
K083865
Life Spine
Orthopedic · 30d
Cleared Jan 13, 2009
CAPSURE PS SYSTEM
K083743
Spine Wave, Inc.
Orthopedic · 28d
Cleared Dec 11, 2008
CAPSURE(R) PS SYSTEM
K083353
Spine Wave, Inc.
Orthopedic · 28d
Cleared Jul 03, 2008
ZODIC POLYAXIAL SPINAL FIXATION SYSTEM
K081158
Alphatec Spine, Inc.
Orthopedic · 71d
Cleared May 21, 2008
CONQUEST SPINAL SYSTEM
K080767
Life Spine
Orthopedic · 64d
Cleared May 12, 2008
CAPSURE PS (R) SPINE SYSTEM
K081228
Spine Wave, Inc.
Orthopedic · 12d
Cleared Apr 08, 2008
MODIFICATION TO:PILOT SPINAL SYSTEM
K080502
Life Spine
Orthopedic · 43d
Cleared Apr 08, 2008
K2M COCR ROD
K080792
K2m, Inc.
Orthopedic · 19d
Cleared Mar 13, 2008
BLACKSTONE SFS PARALLEL ROD CONNECTORS
K080407
Blackstone Medical, Inc.
Orthopedic · 28d
Cleared Feb 14, 2008
MODIFICATION TO STRYKER SPINE OASYS SYSTEM
K080143
Stryker Spine
Orthopedic · 23d
Cleared Jan 28, 2008
QUANTUM-MIS CANNULATED SYSTEM
K080026
Pioneer Surgical Technology
Orthopedic · 24d