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
49–72 of 309
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
Cleared Jun 20, 2002
EQUATION FIXATION SYSTEM
K013962
Medtronic Sofamor Danek, Inc.
Orthopedic · 199d
Cleared May 28, 2002
TSRH SPINAL SYSTEM
K020699
Medtronic Sofamor Danek, Inc.
Orthopedic · 88d
Cleared May 08, 2002
MONARCH SPINE SYSTEM COMMERCIALLY PURE TITANIUM SPINAL ROD
K021148
Depuyacromed
Orthopedic · 28d
Cleared Apr 03, 2002
BLACKSTONE SPINAL FIXATION SYSTEM 4.5MM MULTI-AXIAL SCREW
K020674
Blackstone Medical, Inc.
Orthopedic · 33d
Cleared Apr 03, 2002
EBI OMEGA21 SPINAL FIXATION SYSTEM
K020681
Ebi, L.P.
Orthopedic · 30d
Cleared Feb 14, 2002
OSTEONICS SPINAL SYSTEM
K020293
Howmedica Osteonics Corp.
Orthopedic · 17d
Cleared Jan 25, 2002
MODIFICATION TO OPUS SPINAL SYSTEM
K014229
Howmedica Osteonics Corp.
Orthopedic · 30d
Cleared Jan 16, 2002
MODIFICATION TO EBI OMEGA 21 SYSTEM
K014137
Ebi, L.P.
Orthopedic · 30d
Cleared Dec 27, 2001
MODIFICATION TO TSRH SPINAL SYSTEM
K014076
Medtronic Sofamor Danek, Inc.
Orthopedic · 16d
Cleared Dec 05, 2001
MODIFICATION TO XIA SPINAL SYSTEM
K013688
Howmedica Osteonics Corp.
Orthopedic · 28d
Cleared Oct 09, 2001
MONARCH SPINAL SYSTEMS
K013294
Depuyacromed
Orthopedic · 7d
Cleared Oct 09, 2001
TIMX SPINAL SYSTEMS
K013295
Depuyacromed
Orthopedic · 7d
Cleared Oct 09, 2001
MOSS MIAMI SPINAL SYSTEMS
K013296
Depuyacromed
Orthopedic · 7d
Cleared Oct 05, 2001
ISOLA SPINAL SYSTEMS
K012971
Depuyacromed
Orthopedic · 30d
Cleared Aug 15, 2001
SPIRAL RADIUS 90-D SST SYSTEM
K012273
United States Surgical, A Division of Tyco Healthc
Orthopedic · 27d
Cleared May 16, 2001
MODIFIED MOSS MIAMI 4.35MM DIAMETER POLYAXIAL SCREWS
K011182
Depuyacromed
Orthopedic · 28d
Cleared Apr 18, 2001
MODIFICATION TO OSTEONICS SPINAL SYSTEM
K010845
Howmedica Osteonics Corp.
Orthopedic · 28d
Cleared Apr 12, 2001
MOSS MIAMI 5.5MM TITANIUM PIN NUT
K010742
Depuyacromed
Orthopedic · 30d
Cleared Apr 11, 2001
SOCON SPINAL SYSTEM
K003463
Aesculap, Inc.
Orthopedic · 155d
Cleared Apr 11, 2001
TSRH SPINAL SYSTEM
K010720
Medtronic Sofamor Danek, Inc.
Orthopedic · 30d
Cleared Apr 06, 2001
TRINITY POLYAXIAL SCREW, MEHDIAN SPINAL ROD (6MM), MODEL 159.XXX SERIES CATALOGUE NUMBERS
K010776
Corin USA
Orthopedic · 23d
Cleared Feb 23, 2001
CD HORIZON SPINAL SYSTEM
K010249
Medtronic Sofamor Danek, Inc.
Orthopedic · 28d