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
49–72 of 303
Cleared May 23, 2012
LEXUS CERVICAL FIXATION SYSTEM
K120879
L & K Biomed Co., Ltd.
Orthopedic · 61d
Cleared May 18, 2012
RANGE SPINAL SYSTEM (MESA AND DENALI)
K120099
K2m, Inc.
Orthopedic · 127d
Cleared Apr 25, 2012
SINTEA PLUSTEK PLS MULTI-AXIAL SCREWS
K112611
Sintea Plastek, LLC
Orthopedic · 231d
Cleared Apr 13, 2012
CAPLOX II PEDICLE SCREW SYSTEM
K120292
Captiva Spine, Inc.
Orthopedic · 73d
Cleared Apr 04, 2012
EVEREST SPINAL SYSTEM
K120656
K2m, Inc.
Orthopedic · 30d
Cleared Apr 02, 2012
TIGER SPINE SYSTEM
K120696
Corelink, LLC
Orthopedic · 26d
Cleared Mar 23, 2012
PALLS M SPINAL SYSTEM
K120538
Korea Bone Bank Co., Ltd.
Orthopedic · 30d
Cleared Mar 13, 2012
AILERON INTERSPINOUS FIXATION SYSTEM
K113157
Life Spine
Orthopedic · 139d
Cleared Feb 01, 2012
SYNTHES USS CONNECTORS
K113149
Synthes Spine
Orthopedic · 100d
Cleared Feb 01, 2012
SAVANNAH TECHNOLOGIES SPINAL SYSTEM
K113755
Savannah Technologies, LLC
Orthopedic · 42d
Cleared Jan 20, 2012
RELIANCE SPINAL SCREW SYSTEM
K110896
Reliance Medical Systems, LLC
Orthopedic · 296d
Cleared Dec 21, 2011
RANGE SPINAL SYSTEM (MESA AND DENALI)
K112920
K2m, Inc.
Orthopedic · 79d
Cleared Nov 22, 2011
ZAVATION SPINAL SYSTEM
K112484
Zavation, LLC
Orthopedic · 85d
Cleared Nov 21, 2011
PASS LP SPINAL SYSTEM
K112493
Medicrea International
Orthopedic · 84d
Cleared Oct 18, 2011
SMARTLOC SPINAL FIXATION SYSTEM
K111883
A-Spine Asia, Co., Ltd.
Orthopedic · 109d
Cleared Oct 06, 2011
RANGE SPINAL SYSTEM (MESA AND DENALI)
K112037
K2m, Inc.
Orthopedic · 80d
Cleared Sep 13, 2011
CAPTIVA SPINE CAPLOX II SPINAL FIXATION SYSTEM
K111115
Captiva Spine, Inc.
Orthopedic · 145d
Cleared Aug 31, 2011
CAPSURE(R) PS SYSTEM
K111913
Spine Wave, Inc.
Orthopedic · 56d
Cleared Aug 19, 2011
ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM
K112108
Spineart
Orthopedic · 28d
Cleared Aug 11, 2011
ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM
K111127
Spineart
Orthopedic · 112d
Cleared Aug 02, 2011
MESA SPINAL SYSTEM (KEYSTONE RODS)
K110991
K2m, Inc.
Orthopedic · 116d
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 Jun 08, 2011
NOVEL III SPINAL FIXATION AND ADJUSTABLE BRIDGE SYSTEM
K110284
Medyssey Co, Ltd.
Orthopedic · 127d