MNH · Class II · 21 CFR 888.3070

FDA Product Code MNH: Orthosis, Spondylolisthesis Spinal Fixation

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

309
Total
309
Cleared
127d
Avg days
1995
Since
309 devices
73–96 of 309
Cleared Sep 23, 2008
4CIS SOLAR AND APOLLON SPINE SYSTEMS
K082453
Solco Biomedical Co., Ltd.
Orthopedic · 29d
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 Sep 14, 2007
CAPLESS LI PEDICLE SCREW SYSTEM
K072282
X-Spine Systems, Inc.
Orthopedic · 29d
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
Cleared Sep 14, 2006
OVALTWIST PEDICLE SCREW SYSTEM
K061577
Signus Medizintechnik GmbH
Orthopedic · 99d
Cleared Sep 11, 2006
SFX SNAP-FIT CROSS CONNECTOR
K062196
Depuy Spine, Inc.
Orthopedic · 41d
Cleared Sep 05, 2006
PILOT POSTERIOR LUMBAR PLATING SYSTEM
K061364
Life Spine
Orthopedic · 112d
Cleared Sep 01, 2006
MODIFICATION TO NUVASIVE SPHERX II SYSTEM
K062317
Nuvasive, Inc.
Orthopedic · 23d
Cleared Jul 25, 2006
EBI 5.5 HELICAL FLANGE SPINAL SYSTEM
K061441
Ebi, L.P.
Orthopedic · 62d
Cleared Jul 25, 2006
CD HORIZON SPINAL SYSTEM
K061915
Medtronic Sofamor Danek
Orthopedic · 19d
Cleared Jul 18, 2006
NUVASIVE SPHERX II SYSTEM
K061778
Nuvasive, Inc.
Orthopedic · 22d
Cleared Jul 07, 2006
ZODIAC ADJUSTABLE BRIDGES, MODELS 11-20XX,11-25XX,11-30XX,11-35XX
K061321
Alphatec Spine, Inc.
Orthopedic · 57d
Cleared Jun 22, 2006
4CIS VANE SPINE SYSTEM
K060702
Solco Biomedical Co., Ltd.
Orthopedic · 98d
Cleared Apr 12, 2006
NUVASIVE SPHERX SYSTEM
K060225
Nuvasive, Inc.
Orthopedic · 72d
Cleared Mar 08, 2006
GSS PEDICLE SCREW SYSTEM
K053573
GS Medical Co., Ltd.
Orthopedic · 76d
Cleared Oct 26, 2005
GII SPINAL FIXATION SYSTEM
K051089
Co-Ligne AG
Orthopedic · 181d
Cleared Oct 12, 2005
NV CORMED SOLAS SPINAL SYSTEM
K051959
Nv Cormed
Orthopedic · 86d
Cleared Oct 07, 2005
ARCTEC SEMIRIGID PLATING SYSTEM
K051044
Altiva Corp.
Orthopedic · 165d
Cleared Sep 21, 2005
SELECTIVE-AXIS POSTERIOR NONCERVICAL PLATING SYSTEM
K051697
Medical Device Advisory Development Group
Orthopedic · 90d
Cleared Jul 27, 2005
XIA 4.5 SPINAL SYSTEM
K050461
Stryker Spine
Orthopedic · 154d