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

FDA 510(k) Cleared Orthosis, Spinal Pedicle Fixation Devices (Product Code MNI)

303 devices
1–24 of 303
Cleared Jun 29, 2016
MySpine Pedicle Screw Placement Guides - LP
K153273
Medacta International S.A.
Orthopedic · 230d
Cleared Feb 26, 2016
Sniper (R) Spine System
K160003
Spine Wave, Inc.
Orthopedic · 53d
Cleared Aug 31, 2015
Sniper Spine System
K152174
Spine Wave, Inc.
Orthopedic · 27d
Cleared Jul 31, 2015
Sniper Spine System
K151813
Spine Wave, Inc.
Orthopedic · 29d
Cleared Sep 10, 2014
ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM PREBENT CROSS-CONNECTORS
K141835
Spineart
Orthopedic · 65d
Cleared May 23, 2014
MYSPINE PEDICLE SCREW PLACEMENT GUIDES
K132788
Medacta International
Orthopedic · 259d
Cleared Nov 20, 2013
EVEREST SPINAL SYSTEM
K132757
K2m, Inc.
Orthopedic · 77d
Cleared Oct 03, 2013
EVEREST SPINAL SYSTEM
K132361
K2m, Inc.
Orthopedic · 65d
Cleared Aug 09, 2013
CAPSURE PS SYSTEM
K132154
Spine Wave, Inc.
Orthopedic · 28d
Cleared Oct 11, 2012
CAPSURE(R) PS SYSTEM
K122233
Spine Wave, Inc.
Orthopedic · 77d
Cleared Jun 07, 2012
CAPSURE(R) PS SYSTEM
K120646
Spine Wave, Inc.
Orthopedic · 97d
Cleared May 25, 2012
RANGE SPINAL SYSTEM, UNIT ROD
K120899
K2m, Inc.
Orthopedic · 60d
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 04, 2012
EVEREST SPINAL SYSTEM
K120656
K2m, Inc.
Orthopedic · 30d
Cleared Apr 02, 2012
TIGER SPINE SYSTEM
K120696
Corelink, LLC
Orthopedic · 26d
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 Dec 21, 2011
RANGE SPINAL SYSTEM (MESA AND DENALI)
K112920
K2m, Inc.
Orthopedic · 79d
Cleared Oct 06, 2011
RANGE SPINAL SYSTEM (MESA AND DENALI)
K112037
K2m, Inc.
Orthopedic · 80d
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

About Product Code MNI - Regulatory Context