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
49–72 of 309
Cleared Dec 15, 2011
LANCER PEDICLE SCREW SYSTEM
K110633
Spinal Solutions, LLC
Orthopedic · 286d
Cleared Dec 12, 2011
XINGTM SPINE SYSTEM
K111995
Implanova Co., Ltd.
Orthopedic · 152d
Cleared Nov 22, 2011
DEVINE SPINAL SYSTEM
K111690
Changzhou Orthmed Medical Instrument Co., Ltd.
Orthopedic · 159d
Cleared Sep 26, 2011
PASS LP SPINAL SYSTEM
K110497
Medicrea International
Orthopedic · 216d
Cleared Sep 21, 2011
ODALYS PEDICLE SCREW SYSTEM
K111370
Kalitec Direct, LLC
Orthopedic · 128d
Cleared Jul 21, 2011
REXIOUS SPINAL FIXATION SYSTEM
K111362
Dio Medical Co., Ltd.
Orthopedic · 66d
Cleared Jun 13, 2011
4CIS SOLAR SPINE SYSTEM AND 4CIS APOLLON SPINE SYSTEM
K102458
Solco Biomedical Co., Ltd.
Orthopedic · 290d
Cleared May 25, 2011
TIGER SPINE SYSTEM
K110321
Corelink, LLC
Orthopedic · 111d
Cleared Mar 16, 2011
AAXTER A3 POSTERIOR SPINAL SYSTEM
K101374
Aaxter Co., Ltd.
Orthopedic · 303d
Cleared Mar 07, 2011
PALLA M SPINAL SYSTEM
K102574
Korea Bone Bank Co., Ltd.
Orthopedic · 180d
Cleared Mar 03, 2011
ZENITH PEDICLE SYSTEM
K102636
Apollo Spine, Inc.
Orthopedic · 171d
Cleared Feb 11, 2011
4CIS VANE SPINE SYSTEM
K101818
Solco Biomedical Co., Ltd.
Orthopedic · 226d
Cleared Feb 09, 2011
VENUS BASIC SPINAL FIXATION SYSTEM
K103085
L & K Biomed Co., Ltd.
Orthopedic · 113d
Cleared Jan 25, 2011
FLAMENCO SPINAL FIXATION SYSTEM
K102853
Ulrich GmbH & Co. KG
Orthopedic · 118d
Cleared Jan 21, 2011
EXACTECH PROLIANT POLYAXIAL PEDICLE SCREW SYSTEM
K102870
Exactech, Inc.
Orthopedic · 113d
Cleared Jan 20, 2011
EMERALD SPINAL SYSTEM
K101446
Mazor Surgical Technologies , Ltd.
Orthopedic · 241d
Cleared Dec 20, 2010
INERTIA PEDICLE SCREW SYSTEM
K101278
Nexxt Spine, LLC
Orthopedic · 228d
Cleared Dec 10, 2010
APEX SPINE SYSTEM W/ COCR RODS
K102488
Spinecraft, LLC
Orthopedic · 101d
Cleared Aug 10, 2010
QUANTUM/STREAMLINE TL MIS SPINAL SYSTEM
K093771
Pioneer Surgical Technology
Orthopedic · 245d
Cleared Jul 28, 2010
ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM
K101678
Spineart
Orthopedic · 43d
Cleared Jul 22, 2010
VENUS BASIC SPINAL FIXATION SYSTEM
K100706
L & K Biomed Co., Ltd.
Orthopedic · 132d
Cleared Jul 09, 2010
SPONDY SPINAL FIXATION SYSTEM
K100956
Allure Spine LLC
Orthopedic · 93d
Cleared Jun 30, 2010
TYCHE PEDICLE SCREW SYSTEM
K100373
Kyung Won Medical Co., Ltd.
Orthopedic · 138d
Cleared Jun 04, 2010
MIS SYSTEM
K100605
Spine Wave, Inc.
Orthopedic · 93d