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
169–192 of 303
Cleared Dec 12, 2005
CAPLESS PEDICLE SCREW SYSTEM
K052847
X-Spine Systems, Inc.
Orthopedic · 66d
Cleared Dec 07, 2005
MESA SPINAL SYSTEM
K052398
K2m, LLC
Orthopedic · 98d
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 Nov 07, 2005
UNI-THREAD SPINAL SYSTEM
K052406
Spine Vision, Inc.
Orthopedic · 67d
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 23, 2005
POLYAXIAL HEMISPHERICAL SPINAL SCREWS
K051063
Scient'X
Orthopedic · 27d
Cleared May 17, 2005
CD HORIZON SPINAL SYSTEM
K050981
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 28d
Cleared May 16, 2005
LANX SPINAL FIXATION SYSTEM
K043484
Lanx, LLC
Orthopedic · 150d
Cleared May 04, 2005
LAGUNA PEDICLE SCREW SYSTEM
K050060
Allez Spine, LLC
Orthopedic · 113d
Cleared Apr 11, 2005
EXPEDIUM SPINE SYSTEM SPINOUS PROCESS FUSION PLATE
K050675
Depuy Spine, Inc.
Orthopedic · 26d
Cleared Feb 11, 2005
EASYSPINE SYSTEM
K043094
Ldr Spine USA
Orthopedic · 94d
Cleared Nov 04, 2004
MSD SILO SPINAL SYSTEM
K042210
Medtronic Sofamor Danek
Orthopedic · 80d
Cleared Oct 07, 2004
MODIFICATION TO EQUATION FIXATION SYSTEM
K042453
Medtronic Sofamor Danek, Inc.
Orthopedic · 27d
Cleared Oct 07, 2004
MODIFICATION TO BLACKSTONE MODULAR PEDICLE SCREW SYSTEM
K042514
Blackstone Medical, Inc.
Orthopedic · 21d
Cleared Sep 20, 2004
BLACKSTONE ASCENT POCT SYSTEM 5.5MM/3.0MM SINGLE AXIAL CONNECTOR
K042100
Blackstone Medical, Inc.
Orthopedic · 47d
Cleared Sep 03, 2004
OUTOLOGOUS SPINAL FIXATION SYSTEM
K040493
Orthopedic Sciences, Inc.
Orthopedic · 190d
Cleared Sep 03, 2004
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K041777
Medtronic Sofamor Danek
Orthopedic · 64d
Cleared Jul 01, 2004
ORTHOPEDIC ALLIANCE SPINE SYSTEM
K033826
Orthopedic Alliance, LLC
Orthopedic · 204d
Cleared Jun 30, 2004
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K041030
Medtronic Sofamor Danek
Orthopedic · 70d
Cleared Jun 02, 2004
SUMMIT OCT SPINAL SYSTEM
K041203
Depuy Spine, Inc.
Orthopedic · 26d
Cleared May 28, 2004
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K041118
Medtronic Sofamor Danek
Orthopedic · 29d