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
145–168 of 309
Cleared May 16, 2001
MODIFIED MOSS MIAMI 4.35MM DIAMETER POLYAXIAL SCREWS
K011182
Depuyacromed
Orthopedic · 28d
Cleared May 08, 2001
CLARIS PLATE SYSTEM
K010369
Ortho Tec, LLC
Orthopedic · 90d
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 Mar 19, 2001
TRIFIX SPINAL FIXATION SYSTEM
K010535
Endius, Inc.
Orthopedic · 24d
Cleared Feb 23, 2001
CD HORIZON SPINAL SYSTEM
K010249
Medtronic Sofamor Danek, Inc.
Orthopedic · 28d
Cleared Jan 02, 2001
MODIFICATION TO EBI SPINELINK SYSTEM
K003764
Ebi, L.P.
Orthopedic · 27d
Cleared Dec 22, 2000
CD HORIZON SPINAL SYSTEM
K000641
Medtronic Sofamor Danek, Inc.
Orthopedic · 301d
Cleared Dec 08, 2000
OPUS ROD FIXATION SYSTEM
K003490
Howmedica Osteonics Corp.
Orthopedic · 25d
Cleared Nov 24, 2000
VERSALINK TITANIUM ROD-TO-ROD COUPLERS
K003384
Osteotech, Inc.
Orthopedic · 24d
Cleared Sep 27, 2000
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K002399
Medtronic Sofamor Danek, Inc.
Orthopedic · 51d
Cleared Jul 11, 2000
CD HORIZON SPINAL SYSTEM
K001255
Medtronic Sofamor Danek, Inc.
Orthopedic · 83d
Cleared Jun 22, 2000
CD HORIZON ECLIPSE
K001066
Medtronic Sofamor Danek, Inc.
Orthopedic · 80d
Cleared Jun 03, 2000
TRIFIX SPINAL FIXATION SYSTEM
K001627
Endius, Inc.
Orthopedic · 8d
Cleared May 23, 2000
PASS SPINAL SYSTEM
K001024
Encore Orthopedics, Inc.
Orthopedic · 54d
Cleared May 23, 2000
XIA SPINE SYSTEM HOOKS
K001319
Howmedica Osteonics Corp.
Orthopedic · 27d
Cleared May 10, 2000
COLORADO II SPINAL SYSTEM
K991031
Sofamor Danek USA,Inc.
Orthopedic · 408d
Cleared Apr 14, 2000
HAIDER-UCR SPINAL SYSTEM
K993503
International Advanced Medical Enterprises, Inc.
Orthopedic · 182d
Cleared Apr 10, 2000
5.0MM SPINAL SCREWS
K994288
Ortho Tec, LLC
Orthopedic · 112d
Cleared Mar 30, 2000
COLORADO II SPINAL SYSTEM
K984360
Sofamor Danek USA,Inc.
Orthopedic · 479d
Cleared Mar 10, 2000
MODIFICATION TO CD SPINAL SYSTEM
K000453
Medtronic Sofamor Danek, Inc.
Orthopedic · 28d