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
97–120 of 309
Cleared Mar 26, 1999
TRIFIX PEDICLE SPINAL SCREW ASSEMBLY
K990657
Corin USA
Orthopedic · 25d
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
Cleared Apr 29, 1998
ACROMED TIMX PLATE BASED LOW BACK SYSTEM
K981274
Acromed Corp.
Orthopedic · 21d
Cleared Apr 14, 1998
DEPUY MOTECH MOSS MIAMI SPINAL SYSTEM
K980447
DePuy Orthopaedics, Inc.
Orthopedic · 68d
Cleared Apr 14, 1998
WRIGHT MEDICAL TECHNOLOGY ROD-TO-ROD COUPLER
K980496
Wrightmedicaltechnologyinc
Orthopedic · 64d
Cleared Mar 10, 1998
AURORA TITANIUM SPINAL ROD SYSTEM
K974734
United States Surgical, A Division of Tyco Healthc
Orthopedic · 82d
Cleared Feb 27, 1998
THE MEHDIAN LUMBO-SACRAL PEDICLE SCREW SYSTEM
K973425
Corin USA
Orthopedic · 170d
Cleared Feb 04, 1998
AURORA TITANIUM SPINAL ROD SYSTEM
K974213
United States Surgical, A Division of Tyco Healthc
Orthopedic · 86d
Cleared Sep 19, 1997
DEPUY MOTECH MOSS-MIAMI SPINAL SYSTEM
K972568
Depuy, Inc.
Orthopedic · 71d
Cleared Jun 25, 1997
AESUCLAP SOCON SPINAL SYSTEM
K970285
Aesculap, Inc.
Orthopedic · 152d
Cleared Jun 03, 1997
EASY ROD
K970950
Acromed Corp.
Orthopedic · 81d
Cleared May 08, 1997
ACROMED PEDICLE SCREW
K965102
Acromed Corp.
Orthopedic · 139d
Cleared Mar 14, 1997
ISOLA TWISTER CONNECTOR
K965046
Acromed Corp.
Orthopedic · 86d
Cleared Feb 13, 1997
SYNTHES (U.S.A.) UNIVERSAL SACRAL SYSTEM
K963045
Synthes (Usa)
Orthopedic · 192d
Cleared Feb 11, 1997
OSTEONICS SPINAL SYSTEM - VARIABLE OFFSET CONNECTOR ASSEMBLY
K964544
Osteonics Corp.
Orthopedic · 90d
Cleared Jan 17, 1997
OSTEONICS SPINAL SYSTEM-TOPLOADING TRANSVERSE CONNECTOR ASSEMBLY
K964304
Osteonics Corp.
Orthopedic · 80d
Cleared Jan 16, 1997
SYNERGY(TM) TI POSTERIOR SPINAL SYSTEM
K950099
Buckman Co., Inc.
Orthopedic · 737d
Cleared Jan 09, 1997
MODIFICATION TO THE SYNTHES (USA) UNIVERSAL SPINAL HOOK, ROD, AND AND SACRAL SCREW FIXATION SYSTEM IN 316L STAINLESS STE
K963357
Synthes (Usa)
Orthopedic · 136d
Cleared Dec 16, 1996
ACROMED CABLE/WIRE PEDICLE SCREW
K964007
Acromed Corp.
Orthopedic · 70d