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
97–120 of 309
Cleared Jun 13, 2008
RANGE SPINAL SYSTEM, LARGE DENALI SCREWS
K081381
K2m, Inc.
Orthopedic · 28d
Cleared Jun 06, 2008
PREFERENCE PEDICLE SCREW SYSTEM
K081296
Us Spine
Orthopedic · 30d
Cleared Jun 04, 2008
DVX SPINE SYSTEM
K080876
Bk Meditech, Co., Ltd.
Orthopedic · 65d
Cleared Feb 04, 2008
ACCIN PEDICLE SCREW SYSTEM
K073531
Accelerated Innovation, LLC
Orthopedic · 49d
Cleared Nov 09, 2007
ZODIAC 4.0 POLYAXIAL SPINAL FIXATION SYSTEM
K071890
Alphatec Spine, Inc.
Orthopedic · 123d
Cleared Oct 18, 2007
MODIFICATION TO PASSMED SPINAL SYSTEM
K070530
Medicrea Technologies
Orthopedic · 237d
Cleared Sep 14, 2007
CAPLESS LI PEDICLE SCREW SYSTEM
K072282
X-Spine Systems, Inc.
Orthopedic · 29d
Cleared Jun 13, 2007
LOWTOP PEDICLE SCREW SYSTEM
K070933
Sanacor
Orthopedic · 71d
Cleared Jan 12, 2007
VERTIFLEX SPINAL SCREW SYSTEM
K062670
Vertiflex (Tm), Incorporated
Orthopedic · 127d
Cleared Nov 02, 2006
MODIFICATION TO EXPEDIUM SPINE SYSTEM
K062174
Depuy Spine, Inc.
Orthopedic · 94d
Cleared Sep 26, 2006
ISS INTEGRATED SPINE SYSTEM
K061524
Ortho Development Corp.
Orthopedic · 116d
Cleared Sep 19, 2006
MANTIS SPINAL SYSTEM
K061813
Stryker Spine
Orthopedic · 84d
Cleared Sep 14, 2006
OVALTWIST PEDICLE SCREW SYSTEM
K061577
Signus Medizintechnik GmbH
Orthopedic · 99d
Cleared Sep 11, 2006
SFX SNAP-FIT CROSS CONNECTOR
K062196
Depuy Spine, Inc.
Orthopedic · 41d
Cleared Sep 05, 2006
PILOT POSTERIOR LUMBAR PLATING SYSTEM
K061364
Life Spine
Orthopedic · 112d
Cleared Sep 01, 2006
MODIFICATION TO NUVASIVE SPHERX II SYSTEM
K062317
Nuvasive, Inc.
Orthopedic · 23d
Cleared Jul 26, 2006
BAR PEDICLE SCREW SPINAL FIXATION SYSTEM, MODEL 2020
K061162
Applied Spine Technologies, Inc.
Orthopedic · 91d
Cleared Jul 25, 2006
EBI 5.5 HELICAL FLANGE SPINAL SYSTEM
K061441
Ebi, L.P.
Orthopedic · 62d
Cleared Jul 25, 2006
CD HORIZON SPINAL SYSTEM
K061915
Medtronic Sofamor Danek
Orthopedic · 19d
Cleared Jul 18, 2006
NUVASIVE SPHERX II SYSTEM
K061778
Nuvasive, Inc.
Orthopedic · 22d
Cleared Jul 12, 2006
NFIX FUSION SYSTEM
K053623
N-Spine, Inc.
Orthopedic · 196d
Cleared Jul 07, 2006
ZODIAC ADJUSTABLE BRIDGES, MODELS 11-20XX,11-25XX,11-30XX,11-35XX
K061321
Alphatec Spine, Inc.
Orthopedic · 57d
Cleared Jun 22, 2006
4CIS VANE SPINE SYSTEM
K060702
Solco Biomedical Co., Ltd.
Orthopedic · 98d
Cleared Jun 08, 2006
SSP PEDICLE SCREW SYSTEM
K060118
Specialty Spine Products, LLC
Orthopedic · 142d