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
145–168 of 303
Cleared Jun 08, 2007
SYNAPSE SYSTEM
K070573
Synthes Spine Co.Lp
Orthopedic · 100d
Cleared May 21, 2007
SINGLE PLANAR MULTI AXIAL (SPMA) PEDICLE SCREW SYSTEM
K070295
Trinity Orthopedics, LLC
Orthopedic · 110d
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 24, 2007
4S SPINAL SYSTEM
K063708
Taeyeon Medical Co., Ltd.
Orthopedic · 132d
Cleared Apr 05, 2007
CAPSURE PEDICLE SCREW SYSTEM
K070245
Spine Wave, Inc.
Orthopedic · 70d
Cleared Feb 05, 2007
SCIENT'X SPINAL SYSTEM
K062912
Scient'X
Orthopedic · 131d
Cleared Jan 25, 2007
PILOT SPINAL SYSTEM
K063601
Life Spine
Orthopedic · 52d
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 Oct 06, 2006
PASS 2 SPINAL SYSTEM
K062136
Medicrea
Orthopedic · 72d
Cleared Sep 26, 2006
NEX-LINK SPINAL FIXATION SYSTEM OFFSET CONNECTORS, 2121-XX SERIES
K062505
Abbott Spine, Inc.
Orthopedic · 29d
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 Mar 31, 2006
NEX-LINK SPINAL FIXATION SYSTEM ROD TO ROD CONNECTORS, MODELS 725, 726 SERIES
K060634
Abbott Spine, Inc.
Orthopedic · 22d
Cleared Feb 03, 2006
MODIFICATION TO S4 SPINAL SYSTEM
K060152
Aesculap, Inc.
Orthopedic · 14d
Cleared Jan 06, 2006
NEX-LINK SPINAL FIXATION SYSTEM OPEN POLYAXIAL SCREWS, MODELS 2112, 2113, 2118, 2119, 2120. NEX-LINK SPINAL FIXATION SY
K052566
Abbott Spine, Inc.
Orthopedic · 109d
Cleared Jan 05, 2006
MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM
K053483
Medtronic Sofamor Danek
Orthopedic · 21d