MNH · Class II · 21 CFR 888.3070

FDA Product Code MNH: Orthosis, Spondylolisthesis Spinal Fixation

Leading manufacturers include Acromed Corp., Medtronic Sofamor Danek, Inc. and Depuyacromed.

309
Total
309
Cleared
127d
Avg days
1995
Since

FDA 510(k) Cleared Orthosis, Spondylolisthesis Spinal Fixation Devices (Product Code MNH)

309 devices
1–24 of 309
Cleared Nov 03, 2016
CastleLoc Spinal Fixation System
K162801
L & K Biomed Co., Ltd.
Orthopedic · 29d
Cleared Sep 10, 2015
Romeo posterior osteosynthesis system
K151695
Spineart
Orthopedic · 79d
Cleared May 20, 2014
ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM
K140948
Spineart
Orthopedic · 36d
Cleared Jan 10, 2014
ANNEXTM ADJACENT LEVEL SYSTEM
K132403
Spine Wave, Inc.
Orthopedic · 162d
Cleared May 31, 2013
ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM
K130267
Spineart
Orthopedic · 116d
Cleared Jun 27, 2012
RANGE SPINAL SYSTEM (MESA AND DENALI)
K121016
K2m, Inc.
Orthopedic · 84d
Cleared May 25, 2011
TIGER SPINE SYSTEM
K110321
Corelink, LLC
Orthopedic · 111d
Cleared Feb 09, 2011
VENUS BASIC SPINAL FIXATION SYSTEM
K103085
L & K Biomed Co., Ltd.
Orthopedic · 113d
Cleared Jan 21, 2011
EXACTECH PROLIANT POLYAXIAL PEDICLE SCREW SYSTEM
K102870
Exactech, Inc.
Orthopedic · 113d
Cleared Aug 10, 2010
QUANTUM/STREAMLINE TL MIS SPINAL SYSTEM
K093771
Pioneer Surgical Technology
Orthopedic · 245d
Cleared Jul 28, 2010
ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM
K101678
Spineart
Orthopedic · 43d
Cleared Jul 22, 2010
VENUS BASIC SPINAL FIXATION SYSTEM
K100706
L & K Biomed Co., Ltd.
Orthopedic · 132d
Cleared Jun 04, 2010
MIS SYSTEM
K100605
Spine Wave, Inc.
Orthopedic · 93d
Cleared Mar 18, 2010
MODIFICATION TO: OASYS SYSTEM
K093670
Stryker Spine
Orthopedic · 111d
Cleared Feb 12, 2010
MODIFICATION TO CAPSURE PS SYSTEM
K100122
Spine Wave, Inc.
Orthopedic · 28d
Cleared Apr 29, 2009
ROC LUMBAR PLATING SYSTEM
K090228
Alphatec Spine, Inc.
Orthopedic · 89d
Cleared Mar 04, 2009
MESA SPINAL SYSTEM
K080611
K2m, Inc.
Orthopedic · 365d
Cleared Dec 17, 2008
ELLIPSE LUMBAR POSTERIOR OSTEOSYNTHESIS SYSTEM
K081165
Spineart
Orthopedic · 237d
Cleared Jun 27, 2008
MOUNTAINEER OCT SPINAL SYSTEM
K080828
Depuy Spine, Inc.
Orthopedic · 94d
Cleared Jun 13, 2008
RANGE SPINAL SYSTEM, LARGE DENALI SCREWS
K081381
K2m, Inc.
Orthopedic · 28d
Cleared Nov 09, 2007
ZODIAC 4.0 POLYAXIAL SPINAL FIXATION SYSTEM
K071890
Alphatec Spine, Inc.
Orthopedic · 123d
Cleared Nov 02, 2006
MODIFICATION TO EXPEDIUM SPINE SYSTEM
K062174
Depuy Spine, Inc.
Orthopedic · 94d
Cleared Sep 26, 2006
ISS INTEGRATED SPINE SYSTEM
K061524
Ortho Development Corp.
Orthopedic · 116d
Cleared Sep 19, 2006
MANTIS SPINAL SYSTEM
K061813
Stryker Spine
Orthopedic · 84d

About Product Code MNH - Regulatory Context