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
309 devices
97–120 of 309
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 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
Cleared Apr 12, 2004
NUVASIVE SPINAL SYSTEM
K033546
Nuvasive, Inc.
Orthopedic · 152d
Cleared Feb 12, 2004
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K040072
Medtronic Sofamor Danek, Inc.
Orthopedic · 29d
Cleared Dec 15, 2003
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K033322
Medtronic Sofamor Danek
Orthopedic · 61d
Cleared Jun 27, 2003
ORIA CLARIS
K023378
Ortho Tec, LLC
Orthopedic · 262d
Cleared Jun 27, 2003
EBI P148 SPINAL FIXATION SYSTEM
K031423
Ebi, L.P.
Orthopedic · 52d
Cleared Jun 26, 2003
BLACKSTONE SPINAL FIXATION SYSTEM LATERAL OFFSET (SYSTEM MODIFICATION)
K030581
Blackstone Medical, Inc.
Orthopedic · 122d
Cleared Feb 26, 2003
MODIFICATION TO MOSS MIAMI SPINAL SYSTEM POLYAXIAL SCREWS
K030383
Depuyacromed
Orthopedic · 21d
Cleared Feb 05, 2003
ORIA SPINAL CLIP SYSTEM, TYPES BD AND BJ
K023994
Ortho Tec, LLC
Orthopedic · 64d
Cleared Jan 28, 2003
MONARCH SPINE SYSTEM
K024348
Depuyacromed
Orthopedic · 29d
Cleared Nov 13, 2002
MODIFICATION TO MONARCH SPINE SYSTEM
K023438
Depuyacromed
Orthopedic · 29d