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
121–144 of 303
Cleared Jan 24, 2007
MODIFICATION TO EASYSPINE SYSTEM
K063794
Ldr Spine USA
Orthopedic · 33d
Cleared Dec 22, 2006
TRAVERSE OCT SPINAL FIXATION SYSTEM
K062879
Medtronic Sofamor Danek, Inc.
Orthopedic · 87d
Cleared Nov 16, 2006
SIERRA
K062934
Seaspine, Inc.
Orthopedic · 49d
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 Aug 10, 2006
EASYSPINE SYSTEM
K061017
Ldr Spine USA
Orthopedic · 119d
Cleared Jul 03, 2006
MYKRES SPINAL SYSTEM
K051704
Showa Ika Kohgyo Co., Ltd.
Orthopedic · 374d
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 12, 2005
CAPLESS PEDICLE SCREW SYSTEM
K052847
X-Spine Systems, Inc.
Orthopedic · 66d
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 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