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
73–96 of 309
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 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 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 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
Cleared Mar 10, 2000
MODIFICATION TO CD SPINAL SYSTEM
K000476
Medtronic Sofamor Danek, Inc.
Orthopedic · 25d
Cleared Feb 28, 2000
BLACKSTONE SPINAL FIXATION SYSTEM
K994217
Blackstone Medical, Inc.
Orthopedic · 75d
Cleared Feb 08, 2000
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K000094
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 26d
Cleared Feb 08, 2000
CLICK'X
K992739
Synthes Spine
Orthopedic · 176d
Cleared Feb 03, 2000
MODIFICATION TO ISOBAR SPINAL SYSTEM
K000020
Encore Orthopedics, Inc.
Orthopedic · 30d
Cleared Feb 03, 2000
CD HORIZON SPINAL SYSTEM
K993810
Danek Medical, Inc.
Orthopedic · 85d
Cleared Jan 13, 2000
SOCON SPINAL SYSTEM
K993551
Aesculap, Inc.
Orthopedic · 86d
Cleared Dec 06, 1999
SYNERGY INTEGRAL SCREWS, MODEL NUMBERS 2161,2162,2163,2164,2165,2166,2167,2168,2169,2210,2211,2212,2215,2216,2217,2220
K993808
Interpore Cross Intl.
Orthopedic · 26d
Cleared Sep 14, 1999
DANEK PLATE AND SCREW SYSTEM
K991036
Sofamor Danek USA,Inc.
Orthopedic · 169d
Cleared Aug 27, 1999
OSTEONICS SPINAL SYSTEM- ROD/ PLATE SYSTEM
K991055
Howmedica Osteonics Corp.
Orthopedic · 150d
Cleared Jun 02, 1999
SYNTHES PEDIATRIC ROD SYSTEM
K991552
Synthes (Usa)
Orthopedic · 30d
Cleared May 28, 1999
MODIFICATION TO TENOR SPINAL SYSTEM-ROD/BOLT CONNECTOR
K991528
Danek Medical, Inc.
Orthopedic · 25d
Cleared May 19, 1999
MODIFICATION TO TENOR SPINAL SYSTEM-PLATES
K991364
Sofamor Danek USA,Inc.
Orthopedic · 29d