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
169–192 of 309
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 17, 1999
OMNIAXIAL CONNECTOR
K993926
Ortho Tec, LLC
Orthopedic · 29d
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 27, 1999
ISOLOCK SPINAL SYSTEM
K990721
Scien'Tx USA, Inc.
Orthopedic · 83d
Cleared May 19, 1999
MODIFICATION TO TENOR SPINAL SYSTEM-PLATES
K991364
Sofamor Danek USA,Inc.
Orthopedic · 29d
Cleared May 19, 1999
MODIFICATION TO ZPLATE-ATL ANTERIOR FIXATION SYSTEM
K991460
Sofamor Danek
Orthopedic · 22d
Cleared Mar 26, 1999
TRIFIX PEDICLE SPINAL SCREW ASSEMBLY
K990657
Corin USA
Orthopedic · 25d
Cleared Mar 22, 1999
ISOBAR SPINAL SYSTEM
K990118
Scien'Tx USA, Inc.
Orthopedic · 68d
Cleared Dec 18, 1998
OSTEONICS SPINAL SYSTEM CYLINDRICAL BONE SCREWS
K984302
Osteonics Corp.
Orthopedic · 16d
Cleared Sep 25, 1998
OSTEONICS SPINAL SYSTEM 5.5MM & 10.0MM BONE SCREWS
K983152
Osteonics Corp.
Orthopedic · 16d
Cleared Aug 04, 1998
SYNTHES SPINE PEDIATRIC ROD SYSTEM
K980761
Synthes Spine
Orthopedic · 158d
Cleared Jun 30, 1998
TIMX LOW BACK SYSTEM TITANIUM MX ROD BASED LOW BACK SYSTEM
K981714
Acromed Corp.
Orthopedic · 46d
Cleared May 29, 1998
PEDIATRIC PRC
K981113
Acromed Corp.
Orthopedic · 63d
Cleared May 20, 1998
TITANIUM SPINAL ROD SYSTEM
K980862
United States Surgical, A Division of Tyco Healthc
Orthopedic · 76d