MNH · Class II · 21 CFR 888.3070

FDA Product Code MNH: Orthosis, Spondylolisthesis Spinal Fixation

Leading manufacturers include Howmedica Osteonics Corp., Synthes (Usa) and United States Surgical, A Division of Tyco Healthc.

309
Total
309
Cleared
127d
Avg days
1995
Since

FDA 510(k) Cleared Orthosis, Spondylolisthesis Spinal Fixation Devices (Product Code MNH)

309 devices
1–24 of 309
Cleared Feb 14, 2002
OSTEONICS SPINAL SYSTEM
K020293
Howmedica Osteonics Corp.
Orthopedic · 17d
Cleared Jan 25, 2002
MODIFICATION TO OPUS SPINAL SYSTEM
K014229
Howmedica Osteonics Corp.
Orthopedic · 30d
Cleared Dec 05, 2001
MODIFICATION TO XIA SPINAL SYSTEM
K013688
Howmedica Osteonics Corp.
Orthopedic · 28d
Cleared Aug 15, 2001
SPIRAL RADIUS 90-D SST SYSTEM
K012273
United States Surgical, A Division of Tyco Healthc
Orthopedic · 27d
Cleared Apr 18, 2001
MODIFICATION TO OSTEONICS SPINAL SYSTEM
K010845
Howmedica Osteonics Corp.
Orthopedic · 28d
Cleared Dec 08, 2000
OPUS ROD FIXATION SYSTEM
K003490
Howmedica Osteonics Corp.
Orthopedic · 25d
Cleared May 23, 2000
XIA SPINE SYSTEM HOOKS
K001319
Howmedica Osteonics Corp.
Orthopedic · 27d
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 20, 1998
TITANIUM SPINAL ROD SYSTEM
K980862
United States Surgical, A Division of Tyco Healthc
Orthopedic · 76d
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 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 Feb 13, 1997
SYNTHES (U.S.A.) UNIVERSAL SACRAL SYSTEM
K963045
Synthes (Usa)
Orthopedic · 192d
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 09, 1996
SYNTHES (U.S.A.) UNIVERSAL SPINAL PARALLEL CONNECTOR
K962608
Synthes (Usa)
Orthopedic · 159d
Cleared Sep 17, 1996
VERSALOK SCREW ASSEMBLY (PROPOSED NAME)
K961572
Wrightmedicaltechnologyinc
Orthopedic · 147d
Cleared Feb 15, 1996
MOSS MIAMI SPINAL SYSTEM (ANTERIOR USE)
K953915
Depuy, Inc.
Orthopedic · 178d
Cleared Aug 21, 1995
SYNTHES (U.S.A.) UNIVERSAL SPINAL HOOK, ROD AND PEDICLE/SACRAL SCREW FIXATION SYSTEM
K951626
Synthes (Usa)
Orthopedic · 136d
Cleared Aug 21, 1995
SYNTHES (USA) UNIV. SCREW FIXATION SYSTEM (TITANIUM)
K951794
Synthes (Usa)
Orthopedic · 136d
Cleared Aug 11, 1995
WRIGHT-LOC(TM) SPINAL FIXATION SYSTEM
K950074
Wrightmedicaltechnologyinc
Orthopedic · 214d
Cleared Jun 20, 1995
SIMMONS PLATING SYSTEM BOLT AND SCREW
K930353
Smith & Nephew, Inc.
Orthopedic · 880d

About Product Code MNH - Regulatory Context