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
121–144 of 309
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 Feb 13, 2006
CONTOUR II SPINAL SYSTEM
K053070
Altiva Corp.
Orthopedic · 104d
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
Cleared Jul 19, 2005
HYDRALOK SYSTEM
K051216
Altiva Corp.
Orthopedic · 68d
Cleared Jun 17, 2005
ZODIAC SPINAL FIXATION SYSTEM
K051286
Alphatec/Nexmed
Orthopedic · 30d
Cleared May 12, 2005
4CIS SOLAR SPINE SYSTEM AND 4CIS APOLLON SPINE SYSTEM
K050471
Solco Biomedical Co., Ltd.
Orthopedic · 78d
Cleared Mar 07, 2005
THE 4CIS SPINAL SYSTEM AND 4CIS LOW BACK SYSTEM
K043578
Solco Biomedical Co., Ltd.
Orthopedic · 69d
Cleared Mar 02, 2005
STRYKER SPINE TRIO PS
K043180
Stryker Spine
Orthopedic · 105d
Cleared Feb 18, 2005
ROC LUMBAR PLATING SYSTEM
K050078
Alphatec/Nexmed
Orthopedic · 36d
Cleared Feb 17, 2005
MODIFICATION TO GLOBAL SPINAL FIXATION SYSTEM
K042928
U&I Corp.
Orthopedic · 118d
Cleared Feb 01, 2005
VERTEBRON PSS PEDICLE SCREW SYSTEM
K043152
Vertebron, Inc.
Orthopedic · 78d
Cleared Dec 28, 2004
MODIFICATION TO: CD HORIZON SPINAL SYSTEM
K043343
Medtronic Sofamor Danek
Orthopedic · 22d
Cleared Dec 01, 2004
MX POLYAXIAL PEDICLE SCREW
K043001
Scient'X
Orthopedic · 30d
Cleared Nov 23, 2004
UNI-THREAD SPINAL SYSTEM
K042640
Spine Vision, Inc.
Orthopedic · 57d
Cleared Nov 22, 2004
MX MONOAXIAL PEDICLE SCREW
K042964
Scient'X
Orthopedic · 26d
Cleared Jun 17, 2004
ALADYN RIGID SPINE PLATE
K040747
Scient'X
Orthopedic · 86d
Cleared Jun 03, 2004
PROCYON SPINAL SYSTEM
K033512
Nas Medical Technologies, Inc.
Orthopedic · 210d
Cleared May 20, 2004
PROTEX STABILIZATION SYSTEM
K040442
Globus Medical, Inc.
Orthopedic · 90d
Cleared Apr 21, 2004
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K034056
Medtronic Sofamor Danek
Orthopedic · 113d