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 Medtronic Sofamor Danek.

303
Total
303
Cleared
95d
Avg days
1998
Since
303 devices
121–144 of 303
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 09, 2008
PASS SPINAL SYSTEM
K080099
Medicrea Technologies
Orthopedic · 86d
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 Apr 07, 2008
MODIFIED VERTIFLEX SPINAL SCREW SYSTEM
K073143
Vertiflex, Inc.
Orthopedic · 152d
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 28, 2008
MODIFICATION TO: VERTEFIX PEDICLE SCREW SPINAL SYSTEM
K080075
Elite Surgical Supplies (Pty), Ltd.
Orthopedic · 17d
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 Nov 01, 2007
MEGA SPINE SYSTEM
K072436
Bk Meditech, Co., Ltd.
Orthopedic · 63d
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 Sep 21, 2007
MODIFICATION TO PASSMED SPINAL SYSTEM
K070276
Medicrea Technologies
Orthopedic · 235d
Cleared Sep 17, 2007
LANX SPINAL FIXATION SYSTEM
K071877
Lanx, LLC
Orthopedic · 70d
Cleared Sep 04, 2007
ACME TALON PEDICLE SCREW
K071824
Acme Spine, LLC
Orthopedic · 63d
Cleared Aug 30, 2007
VERTEFIX PEDICLE SCREW SPINAL SYSTEM
K063453
Elite Surgical Supplies (Pty), Ltd.
Orthopedic · 288d
Cleared Aug 21, 2007
PSS SYSTEM
K071438
Spinal USA
Orthopedic · 90d
Cleared Aug 08, 2007
DELTA SPINAL FUSION SYSTEM
K071857
Jemo Spine, LLC
Orthopedic · 34d
Cleared Aug 06, 2007
NUVASIVE OCT SYSTEM
K071435
Nuvasive, Inc.
Orthopedic · 75d
Cleared Jul 06, 2007
PILLAR PEDICLE SCREW SYSTEM
K071743
The 4th Column, LLC
Orthopedic · 9d