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
121–144 of 309
Cleared Oct 18, 2002
MODIFICATION TO EBI OMEGA21 SPINAL FIXATION SYSTEM
K023204
Ebi, L.P.
Orthopedic · 23d
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
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 Feb 12, 2002
BACFIX SPINAL FIXATION SYSTEM
K013887
Spinal Concepts, Inc.
Orthopedic · 81d
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 29, 2001
SCS CLOSED SCREW
K003733
Ortho Tec, LLC
Orthopedic · 176d