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 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 Nov 05, 2008
MODIFICATION TO 4CIS VANE SPINE SYSTEM
K081145
Solco Biomedical Co., Ltd.
Orthopedic · 197d
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 May 21, 2008
CONQUEST SPINAL SYSTEM
K080767
Life Spine
Orthopedic · 64d
Cleared May 12, 2008
CAPSURE PS (R) SPINE SYSTEM
K081228
Spine Wave, Inc.
Orthopedic · 12d
Cleared Apr 08, 2008
MODIFICATION TO:PILOT SPINAL SYSTEM
K080502
Life Spine
Orthopedic · 43d
Cleared Apr 08, 2008
K2M COCR ROD
K080792
K2m, Inc.
Orthopedic · 19d
Cleared Mar 20, 2008
PSS SYSTEM
K073240
Spinal USA
Orthopedic · 125d
Cleared Mar 13, 2008
BLACKSTONE SFS PARALLEL ROD CONNECTORS
K080407
Blackstone Medical, Inc.
Orthopedic · 28d
Cleared Feb 14, 2008
MODIFICATION TO STRYKER SPINE OASYS SYSTEM
K080143
Stryker Spine
Orthopedic · 23d
Cleared Jan 28, 2008
QUANTUM-MIS CANNULATED SYSTEM
K080026
Pioneer Surgical Technology
Orthopedic · 24d
Cleared Jan 10, 2008
SYNTHES OC FUSION AND SYNAPSE SYSTEMS
K072434
Synthes Spine Co.Lp
Orthopedic · 134d
Cleared Jan 03, 2008
NATURAL BRIDGE LP TRANSVERSE CONNECTORS
K072914
K2m, Inc.
Orthopedic · 83d
Cleared Oct 12, 2007
PIONEER LOWTOP SPINAL ROD SYSTEM
K072187
Pioneer Surgical Technology
Orthopedic · 67d
Cleared Oct 05, 2007
Optima ZS Transition Screw
K071880
Zimmer Spine, Inc.
Orthopedic · 88d
Cleared Aug 21, 2007
PSS SYSTEM
K071438
Spinal USA
Orthopedic · 90d
Cleared Aug 06, 2007
NUVASIVE OCT SYSTEM
K071435
Nuvasive, Inc.
Orthopedic · 75d
Cleared Jun 08, 2007
SYNAPSE SYSTEM
K070573
Synthes Spine Co.Lp
Orthopedic · 100d
Cleared May 18, 2007
ROC LUMBAR SYSTEM
K063668
Alphatec Spine, Inc.
Orthopedic · 158d
Cleared May 03, 2007
RANGE SPINAL SYSTEM
K070229
K2m, Inc.
Orthopedic · 99d
Cleared Apr 05, 2007
CAPSURE PEDICLE SCREW SYSTEM
K070245
Spine Wave, Inc.
Orthopedic · 70d
Cleared Jan 25, 2007
PILOT SPINAL SYSTEM
K063601
Life Spine
Orthopedic · 52d