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
145–168 of 309
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 Jan 20, 2004
GII SPINAL FIXATION SYSTEM
K032604
Co-Ligne AG
Orthopedic · 148d
Cleared Dec 15, 2003
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K033322
Medtronic Sofamor Danek
Orthopedic · 61d
Cleared Dec 10, 2003
STRYKER SPINE MAPS SYSTEM
K032855
Howmedica Osteonics
Orthopedic · 89d
Cleared Oct 09, 2003
SHIRAZ-JAVA SPINAL FIXATION SYSTEM
K031265
Spine Next SA
Orthopedic · 171d
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 27, 2003
U&I, OPTIMA, SPINAL SYSTEM
K031585
U&I Corp., America
Orthopedic · 37d
Cleared Jun 26, 2003
BLACKSTONE SPINAL FIXATION SYSTEM LATERAL OFFSET (SYSTEM MODIFICATION)
K030581
Blackstone Medical, Inc.
Orthopedic · 122d
Cleared May 13, 2003
MODIFICATION TO EASYS TRANSVERSE CONNECTION
K031290
Scient'X USA, Inc.
Orthopedic · 20d
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 Dec 10, 2002
SINTEA BIOTECH POSTERIOR LUMBAR SYSTEM, MODEL PLS 00.T5.X
K020085
Sintea Biotech, Inc.
Orthopedic · 334d
Cleared Nov 13, 2002
MODIFICATION TO MONARCH SPINE SYSTEM
K023438
Depuyacromed
Orthopedic · 29d
Cleared Oct 18, 2002
MODIFICATION TO EBI OMEGA21 SPINAL FIXATION SYSTEM
K023204
Ebi, L.P.
Orthopedic · 23d
Cleared Sep 10, 2002
UCR SPINAL SYSTEM, 5.5MM, 8.0MM SCREWS & INSTRUMENTS
K021623
Iame, Inc.
Orthopedic · 117d
Cleared Jul 29, 2002
ENDIUS TITLE SPINAL FIXATION SYSTEM
K021881
Endius, Inc.
Orthopedic · 52d
Cleared Jul 23, 2002
ALPHA MIRAGE TOP TIGHTENING SPINAL SYSTEM
K020356
Alphatec Mfg., Inc.
Orthopedic · 169d
Cleared Jul 22, 2002
COLORADO 2 SPINAL SYSTEM
K020247
Medtronic Sofamor Danek, Inc.
Orthopedic · 179d
Cleared Jul 11, 2002
MONARCH SPINE SYSTEM
K021335
Depuyacromed
Orthopedic · 76d
Cleared Jun 26, 2002
CROSSOVER CROSS CONNECTOR (ISOLA SPINAL SYSTEM)
K021879
Depuyacromed
Orthopedic · 19d
Cleared Jun 26, 2002
CROSSOVER CROSS CONNECTOR (MOSS MIAMI SPINE SYSTEM)
K021880
Depuyacromed
Orthopedic · 19d