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
193–216 of 309
Cleared May 01, 1998
GII SPINAL FIXATION SYSTEM
K980852
Karen E. Warden, M.E.B.E.
Orthopedic · 57d
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 18, 1998
SPINAL CONCEPTS, INC., BACFIX TI SPINAL FIXATION SYSTEM
K973687
Spinal Concepts, Inc.
Orthopedic · 173d
Cleared Mar 13, 1998
SYNERGY CLOSED VARIABLE LOCKING SCREW (VLS), PART OF THE CROSS MEDICAL-SYNERGY ANTERIOR AND POSTERIOR SPINAL SYSTEMS
K974749
Cross Medical Products, Inc.
Orthopedic · 84d
Cleared Mar 10, 1998
AURORA TITANIUM SPINAL ROD SYSTEM
K974734
United States Surgical, A Division of Tyco Healthc
Orthopedic · 82d
Cleared Mar 05, 1998
SYNERGY 6.35MM SS ROD WITH SCREWS FOR ANTERIOR USE, PART OF THE CROSS MEDICAL-SYNERGY ANTERIOR SPINAL SYSTEM
K973836
Cross Medical Products, Inc.
Orthopedic · 148d
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 Dec 24, 1997
OMEGA 21 SYSTEM
K973683
Ebi Electro Biology
Orthopedic · 89d
Cleared Sep 19, 1997
DEPUY MOTECH MOSS-MIAMI SPINAL SYSTEM
K972568
Depuy, Inc.
Orthopedic · 71d
Cleared Aug 20, 1997
EBI SPINELINK SYSTEM
K971970
Electro-Biology, Inc.
Orthopedic · 83d
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 Apr 09, 1997
EBI SPINELINK SYSTEM
K964533
Electro-Biology, Inc.
Orthopedic · 148d
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