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 Dec 29, 2010
ZENIUS SPINAL SYSTEM
K103272
Medyssey Co, Ltd.
Orthopedic · 54d
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
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 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 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 19, 2009
KRD1 PEDICLE SCREW SYSTEM
K092420
Spinefrontier, Inc.
Orthopedic · 105d
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 Sep 14, 2009
MODIFICATION TO: PSS SYSTEM
K092128
Spinal USA
Orthopedic · 61d
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 Jun 30, 2009
INERTIA PEDICLE SCREW SYSTEM
K090984
Nexxt Spine, LLC
Orthopedic · 84d
Cleared May 06, 2009
MODIFICATION TO: PSS SYSTEM
K090033
Spinal USA
Orthopedic · 120d
Cleared Mar 27, 2009
THEKEN ATOLL OCT SPINAL SYSTEM
K083863
Theken Spine, LLC
Orthopedic · 88d
Cleared Mar 26, 2009
RELIANCE SPINAL SCREW SYSTEM
K081978
Reliance Medical Systems, LLC
Orthopedic · 258d
Cleared Mar 13, 2009
THEKEN ATOLL CERVICO-THORACIC SYSTEM
K083073
Theken Spine, LLC
Orthopedic · 149d
Cleared Jan 28, 2009
PILOT SPINAL SYSTEM
K083865
Life Spine
Orthopedic · 30d