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
73–96 of 309
Cleared Mar 18, 2010
MODIFICATION TO: OASYS SYSTEM
K093670
Stryker Spine
Orthopedic · 111d
Cleared Feb 12, 2010
MODIFICATION TO CAPSURE PS SYSTEM
K100122
Spine Wave, Inc.
Orthopedic · 28d
Cleared Nov 09, 2009
PERFIX SPINAL SYSTEM, MODEL SNA4530-9610, SNM4530-9610, SN3020 (TOTAL: 549)
K091725
U&I Corp.
Orthopedic · 151d
Cleared Oct 28, 2009
NORM SPINAL SYSTEM
K092011
Norm Tibbi Urunler Ithalat Ihracat Sanayi VE Ticar
Orthopedic · 114d
Cleared Oct 26, 2009
ULC SPINAL PEDICLE SCREW SYSTEM
K083077
Otis Biotech Co., Ltd.
Orthopedic · 375d
Cleared Sep 14, 2009
GII SPINAL FIXATION SYSTEM, GII-TI-POLY AXIAL SCREW
K083567
Co-Ligne AG
Orthopedic · 285d
Cleared Jul 30, 2009
FORTEX PEDICLE SCREW SYSTEM
K090224
X-Spine Systems, Inc.
Orthopedic · 181d
Cleared Jul 27, 2009
ALPINE PEDICLE SCREW SYSTEM
K090477
Sanacor
Orthopedic · 153d
Cleared Jul 24, 2009
SPINAL EDGE TITAN PEDICLE SCREW SYSTEM
K091110
Spinal Edge, LLC
Orthopedic · 98d
Cleared May 14, 2009
DVX SPINE SYSTEM
K090424
Bk Meditech, Co., Ltd.
Orthopedic · 84d
Cleared Apr 29, 2009
ROC LUMBAR PLATING SYSTEM
K090228
Alphatec Spine, Inc.
Orthopedic · 89d
Cleared Apr 07, 2009
LANX SPINAL FIXATION SYSTEM
K083581
Lanx, Inc.
Orthopedic · 124d
Cleared Mar 04, 2009
MESA SPINAL SYSTEM
K080611
K2m, Inc.
Orthopedic · 365d
Cleared Jan 30, 2009
NOVEL SPINAL SYSTEM
K081153
Medyssey Co, Ltd.
Orthopedic · 282d
Cleared Jan 22, 2009
LAGUNA POLYAXIAL PEDICLE SCREW SYSTEM
K083826
Allez Spine, LLC
Orthopedic · 30d
Cleared Dec 17, 2008
ELLIPSE LUMBAR POSTERIOR OSTEOSYNTHESIS SYSTEM
K081165
Spineart
Orthopedic · 237d
Cleared Dec 15, 2008
EOS SPINAL SYSTEM
K082509
Korea Bone Bank Co., Ltd.
Orthopedic · 108d
Cleared Oct 03, 2008
PASS LP SPINAL SYSTEM
K082577
Medicrea Technologies
Orthopedic · 28d
Cleared Sep 24, 2008
MODIFICATION TO PREFERENCE PEDICLE SCREW SYSTEM
K081883
Us Spine
Orthopedic · 84d
Cleared Sep 23, 2008
4CIS SOLAR AND APOLLON SPINE SYSTEMS
K082453
Solco Biomedical Co., Ltd.
Orthopedic · 29d
Cleared Jul 23, 2008
FIXXSURE CROSS LINK
K081331
Spineworks, LLC
Orthopedic · 72d
Cleared Jul 18, 2008
SINTEA BIOTECH PLS MULTI-AXIAL SCREWS
K081631
Sintea Biotech, Inc.
Orthopedic · 37d
Cleared Jun 27, 2008
MOUNTAINEER OCT SPINAL SYSTEM
K080828
Depuy Spine, Inc.
Orthopedic · 94d
Cleared Jun 27, 2008
GPS, G SURGICAL PEDICLE SYSTEM
K081041
G Surgical Co., Ltd.
Orthopedic · 77d