MNI · Class II · 21 CFR 888.3070

FDA Product Code MNI: Orthosis, Spinal Pedicle Fixation

Leading manufacturers include K2m, Inc., Medtronic Sofamor Danek, Inc. and Spine Wave, Inc..

303
Total
303
Cleared
95d
Avg days
1998
Since
303 devices
97–120 of 303
Cleared Nov 04, 2009
ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM
K093170
Spineart
Orthopedic · 28d
Cleared Sep 14, 2009
MODIFICATION TO: PSS SYSTEM
K092128
Spinal USA
Orthopedic · 61d
Cleared Jul 31, 2009
PASS LP SPINAL SYSTEM
K083810
Medicrea Technologies
Orthopedic · 221d
Cleared Jul 08, 2009
ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM
K091189
Alphatec Spine, Inc.
Orthopedic · 76d
Cleared Jul 07, 2009
ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM
K090779
Alphatec Spine, Inc.
Orthopedic · 106d
Cleared Jun 30, 2009
INERTIA PEDICLE SCREW SYSTEM
K090984
Nexxt Spine, LLC
Orthopedic · 84d
Cleared May 06, 2009
MODIFICATION TO: PSS SYSTEM
K090033
Spinal USA
Orthopedic · 120d
Cleared Mar 27, 2009
THEKEN ATOLL OCT SPINAL SYSTEM
K083863
Theken Spine, LLC
Orthopedic · 88d
Cleared Mar 26, 2009
RELIANCE SPINAL SCREW SYSTEM
K081978
Reliance Medical Systems, LLC
Orthopedic · 258d
Cleared Mar 13, 2009
THEKEN ATOLL CERVICO-THORACIC SYSTEM
K083073
Theken Spine, LLC
Orthopedic · 149d
Cleared Feb 23, 2009
SOLAS ANATOMIX SPINAL SYSTEM
K083178
Biotechni America Spine Group, Inc.
Orthopedic · 118d
Cleared Jan 28, 2009
PILOT SPINAL SYSTEM
K083865
Life Spine
Orthopedic · 30d
Cleared Jan 15, 2009
TRAUSON GENERAL SPINAL SYSTEM (GSS)
K082617
Trauson (Jiangsu) Medical Instrument Co., Ltd.
Orthopedic · 128d
Cleared Jan 13, 2009
CAPSURE PS SYSTEM
K083743
Spine Wave, Inc.
Orthopedic · 28d
Cleared Dec 11, 2008
CAPSURE(R) PS SYSTEM
K083353
Spine Wave, Inc.
Orthopedic · 28d
Cleared Dec 10, 2008
PASS LP SPINAL SYSTEM
K083308
Medicrea Technologies
Orthopedic · 30d
Cleared Nov 05, 2008
MODIFICATION TO 4CIS VANE SPINE SYSTEM
K081145
Solco Biomedical Co., Ltd.
Orthopedic · 197d
Cleared Oct 03, 2008
PASS 2 SPINAL SYSTEM
K082069
Medicrea Technologies
Orthopedic · 73d
Cleared Jul 24, 2008
MODIFICATION TO SINGLE PLANAR MULTI AXIS (SPMA) PEDICLE SCREW SYSTEM
K081790
Trinity Orthopedics, LLC
Orthopedic · 29d
Cleared Jul 23, 2008
COSMIC SYSTEM
K080841
Ulrich GmbH & Co. KG
Orthopedic · 119d
Cleared Jul 03, 2008
ZODIC POLYAXIAL SPINAL FIXATION SYSTEM
K081158
Alphatec Spine, Inc.
Orthopedic · 71d
Cleared Jul 02, 2008
MYKRES SPINAL SYSTEM
K071074
Showa Ika Kohgyo Co., Ltd.
Orthopedic · 443d
Cleared Jul 02, 2008
ORTHOBIOM SPINAL SYSTEM
K071668
Paradigm Spine
Orthopedic · 379d
Cleared Jul 02, 2008
MODIFICATION TO VERTEBRON PSS PEDICLE SCREW SYSTEM
K081597
Vertebron, Inc.
Orthopedic · 26d