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
193–216 of 303
Cleared Mar 31, 2004
MODIFICATION TO: CD HORIZON SPINAL SYSTEM
K040583
Medtronic Sofamor Danek
Orthopedic · 26d
Cleared Mar 12, 2004
MODIFICATION TO ORIA TOP CLIP SYSTEM
K040346
Ortho Tec, LLC
Orthopedic · 29d
Cleared Mar 04, 2004
SHIRAZ POSTERIOR SYSTEM
K033947
Spine Next America
Orthopedic · 76d
Cleared Mar 01, 2004
ART POSTERIOR SPINAL SYSTEM
K033150
Advanced Medical Technologies AG
Orthopedic · 153d
Cleared Feb 25, 2004
VERTEBRON PSS PEDICLE SCREW SYSTEM
K033352
Vertebron, Inc.
Orthopedic · 128d
Cleared Feb 20, 2004
STRYKER SPINE OASYS SYSTEM
K032394
Howmedica Osteonics Corp.
Orthopedic · 200d
Cleared Feb 11, 2004
BLACKSTONE ASCENT POCT SYSTEM LATERAL OFFSET ADAPTER
K040034
Blackstone Medical, Inc.
Orthopedic · 34d
Cleared Jan 27, 2004
PLUS PIVOT LINK UNIVERSAL SYSTEM
K033508
Spine Vision, Inc.
Orthopedic · 82d
Cleared Jan 27, 2004
SHIRAZ-JAVA SPINAL FIXATION SYSTEM
K033772
Spine Next America
Orthopedic · 55d
Cleared Jan 22, 2004
POSTERIOR CABLE SCREW
K022908
Pioneer Surgical Technology
Orthopedic · 506d
Cleared Dec 19, 2003
REVOLUTION SPINAL FIXATION SYSTEM
K032219
Spinal Innovations, Inc.
Orthopedic · 151d
Cleared Dec 03, 2003
MODIFICATION TO EQUATION FIXATION SYSTEM
K033495
Medtronic Sofamor Danek, Inc.
Orthopedic · 28d
Cleared Nov 20, 2003
ORIA SPINAL SYSTEM, DOMINO AND TUBE CONNECTORS
K030958
Ortho Tec, LLC
Orthopedic · 238d
Cleared Nov 20, 2003
UCR SPINAL SYSTEM
K032739
Seaspine
Orthopedic · 77d
Cleared Nov 06, 2003
DYNALOK CLASSIC SPINAL SYSTEM
K033271
Medtronic Sofamor Danek
Orthopedic · 27d
Cleared Oct 31, 2003
PLUS PIVOT LINK UNIVERSAL SYSTEM
K032398
Spine Vision, Inc.
Orthopedic · 88d
Cleared Oct 22, 2003
CONKLUSION PEDICLE SCREW SYSTEM
K031455
Signus Medical, LLC
Orthopedic · 168d
Cleared Sep 17, 2003
TSRH SPINAL SYSTEM
K031967
Medtronic Sofamor Danek, Inc.
Orthopedic · 83d
Cleared Sep 17, 2003
TSRH SPINAL SYSTEM
K032578
Medtronic Sofamor Danek, Inc.
Orthopedic · 27d
Cleared Sep 11, 2003
SPINAL CONCEPTS INC. NEX-LINK SPINAL FIXATION SYSTEM
K031985
Spinal Concepts, Inc.
Orthopedic · 76d
Cleared Sep 04, 2003
CD HORIZON (ADDITION OF SPINOUS PROCESS PLATE)
K032037
Medtronic Sofamor Danek
Orthopedic · 65d
Cleared Sep 03, 2003
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K031833
Medtronic Sofamor Danek
Orthopedic · 82d
Cleared Aug 29, 2003
MODIFICATION TO UNIVERSAL MULTIAXIS (UNIMAX) PEDICLE SCREW SYSTEM
K024313
Pisharodi Surgicals, Inc.
Orthopedic · 248d
Cleared Aug 06, 2003
EBI OMEGA21 SPINAL FIXATION SYSTEM
K031354
Ebi, L.P.
Orthopedic · 99d