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
49–72 of 303
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 06, 2007
NUVASIVE OCT SYSTEM
K071435
Nuvasive, Inc.
Orthopedic · 75d
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
Cleared Dec 22, 2006
TRAVERSE OCT SPINAL FIXATION SYSTEM
K062879
Medtronic Sofamor Danek, Inc.
Orthopedic · 87d
Cleared Oct 24, 2006
MODIFICATION TO STRYKER SPINE OASYS SYSTEM
K062853
Stryker Spine
Orthopedic · 29d
Cleared Oct 11, 2006
TRIO + SPINAL SYSTEM
K062698
Stryker Spine
Orthopedic · 30d
Cleared Sep 25, 2006
CD HORIZON SPINAL SYSTEM
K062606
Medtronic Sofamor Danek
Orthopedic · 20d
Cleared Aug 22, 2006
ARX SPINAL SYSTEM
K061600
Life Spine
Orthopedic · 75d
Cleared Aug 11, 2006
EBI, L.P.'S LINE EXTENSION TO THE ARRAY SPINAL SYSTEM
K061978
Ebi, L.P.
Orthopedic · 29d
Cleared Feb 03, 2006
MODIFICATION TO S4 SPINAL SYSTEM
K060152
Aesculap, Inc.
Orthopedic · 14d
Cleared Jan 05, 2006
MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM
K053483
Medtronic Sofamor Danek
Orthopedic · 21d
Cleared Dec 06, 2005
XIA SPINAL SYSTEM
K053115
Stryker Spine
Orthopedic · 29d
Cleared Nov 16, 2005
STRYKER SPINE TRIO SPINAL FIXATION SYSTEM
K052971
Stryker Spine
Orthopedic · 23d
Cleared Oct 11, 2005
MODIFICATION TO: XIA 4.5 SPINAL SYSTEM
K052761
Stryker Spine
Orthopedic · 11d
Cleared Sep 21, 2005
MODIFICATION TO: STRYKER SPINE OASYS SYSTEM
K052317
Stryker Spine
Orthopedic · 27d
Cleared Jul 27, 2005
S4 SPINAL SYSTEM
K050979
Aesculap, Inc.
Orthopedic · 99d
Cleared May 17, 2005
CD HORIZON SPINAL SYSTEM
K050981
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 28d
Cleared Apr 11, 2005
EXPEDIUM SPINE SYSTEM SPINOUS PROCESS FUSION PLATE
K050675
Depuy Spine, Inc.
Orthopedic · 26d
Cleared Nov 04, 2004
MSD SILO SPINAL SYSTEM
K042210
Medtronic Sofamor Danek
Orthopedic · 80d