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 May 19, 2011
ZENIUS SPINAL SYSTEM
K110283
Medyssey Co, Ltd.
Orthopedic · 107d
Cleared Mar 17, 2011
EVEREST SPINAL SYSTEM
K103440
K2m, Inc.
Orthopedic · 114d
Cleared Feb 08, 2011
LEUCADIA PEDICLE SCREW SYSTEM
K103102
Phygen, LLC
Orthopedic · 111d
Cleared Feb 02, 2011
TALON SPINAL SYSTEM
K102995
Spine360
Orthopedic · 117d
Cleared Dec 29, 2010
ZENIUS SPINAL SYSTEM
K103272
Medyssey Co, Ltd.
Orthopedic · 54d
Cleared Dec 16, 2010
NOVEL III SPINAL FIXATION AND ADJUSTABLE BRIDGE SYSTEM
K103147
Medyssey Co, Ltd.
Orthopedic · 52d
Cleared Dec 07, 2010
S 100 PEDICLE SCREW SYSTEM
K101682
Renovis Surgical Technologies, LLC
Orthopedic · 175d
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 Oct 15, 2010
KAPSS SPINAL SYSTEM
K093833
Robert Reid, Inc.
Orthopedic · 305d
Cleared Oct 15, 2010
LDR SPINE USA SPINETUNE TL SPINAL SYSTEM
K102331
Ldr Spine USA
Orthopedic · 59d
Cleared Aug 02, 2010
RANGE SPINAL SYSTEM
K100851
K2m, Inc.
Orthopedic · 129d
Cleared Jul 19, 2010
FIXPINE II SYSTEM
K100765
Dio Medical Co., Ltd.
Orthopedic · 124d
Cleared Jun 25, 2010
MEDYSSEY CO., LTD., ZENIUS SPINAL SYSTEM
K093104
Medyssey Co, Ltd.
Orthopedic · 267d
Cleared Apr 22, 2010
DIAMONDBACK SPINAL SYSTEM
K100377
Eminent Spine
Orthopedic · 69d
Cleared Apr 02, 2010
AEGIS & AEGIS II SPINAL SYSTEM
K092076
Corentec Co., Ltd.
Orthopedic · 267d
Cleared Mar 31, 2010
LDR SPINE USA SPINE TUNE TL SPINE SYSTEM
K100575
Ldr Spine USA
Orthopedic · 30d
Cleared Mar 11, 2010
ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM
K093936
Spineart
Orthopedic · 79d
Cleared Mar 04, 2010
PASS LP SPINAL SYSTEM
K100297
Medicrea Technologies
Orthopedic · 30d
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 Dec 10, 2009
MODIFICATION TO LANX SPINAL FIXATION SYSTEM
K093285
Lanx, LLC
Orthopedic · 51d
Cleared Nov 19, 2009
KRD1 PEDICLE SCREW SYSTEM
K092420
Spinefrontier, Inc.
Orthopedic · 105d
Cleared Nov 06, 2009
CASPIAN SPINAL SYSTEM
K092640
K2m, Inc.
Orthopedic · 71d