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
193–216 of 303
Cleared Jun 06, 2001
SYNERGY 4.0 MM, 4.5 MM VLS SCREWS
K011437
Interpore Cross Intl.
Orthopedic · 27d
Cleared Jun 05, 2001
MODIFICATION TO TSRH SPINAL SYSTEM
K011029
Medtronic Sofamor Danek, Inc.
Orthopedic · 61d
Cleared Jun 04, 2001
MODIFIED USS FRACTURE SYSTEM
K010658
Synthes (Usa)
Orthopedic · 90d
Cleared May 25, 2001
END-TO-END AND SIDE-BY-SIDE CONNECTORS
K010563
Spinal Concepts, Inc.
Orthopedic · 88d
Cleared May 23, 2001
MONARCH SPINE SYSTEM
K010576
Depuyacromed
Orthopedic · 85d
Cleared May 08, 2001
BLACKSTONE SPINAL FIXATION SYSTEM, SECOND-GENERATION CROSS-CONNECTOR
K003735
Blackstone Medical, Inc.
Orthopedic · 155d
Cleared May 04, 2001
MODIFICATION TO TSRH SPINAL SYSTEM
K011067
Medtronic Sofamor Danek, Inc.
Orthopedic · 25d
Cleared Oct 17, 2000
SMALL STATURE USS
K994121
Synthes (Usa)
Orthopedic · 316d
Cleared Jun 01, 2000
TRI-FIX SPINAL FIXATION SYSTEM
K000766
Endius, Inc.
Orthopedic · 84d
Cleared May 11, 2000
MULTI-AXIAL CROSS (MAC) CONNECTOR
K000965
Howmedica Osteonics Corp.
Orthopedic · 45d
Cleared Apr 18, 2000
SYNERGY ADJUSTABLE TRANSVERSE CONNECTOR ROD, SYNERGY ADJUSTABLE TRANSVERSE CONNECTOR LAMP
K000876
Interpore Cross Intl.
Orthopedic · 29d
Cleared Apr 18, 2000
MODIFICATION TO TSRH SPINAL SYSTEM
K000991
Medtronic Sofamor Danek, Inc.
Orthopedic · 21d
Cleared Apr 14, 2000
MODIFICATION TO EBI SPINELINK SYSTEM
K001037
Ebi, L.P.
Orthopedic · 14d
Cleared Mar 10, 2000
MODIFICATION TO SYNTHES USS
K000450
Synthes Spine
Orthopedic · 28d
Cleared Mar 07, 2000
ISOBAR SPINAL SYSTEM
K000425
Encore Orthopedics, Inc.
Orthopedic · 27d
Cleared Feb 28, 2000
TRIPLE-FIX SPINAL FIXATION SYSTEM
K992147
Advanced Spine Technology, Inc.
Orthopedic · 249d
Cleared Feb 16, 2000
SYNERGY VLS CAP NUT MODELS 2206, 6102
K000236
Interpore Cross Intl.
Orthopedic · 20d
Cleared Jan 13, 2000
MICOMED POSTERIOR DOUBLEROD SYSTEM (MPDS)
K991862
Micomed GmbH
Orthopedic · 226d
Cleared Dec 20, 1999
OPUS SPINAL SYSTEM
K993402
Howmedica Osteonics Corp.
Orthopedic · 73d
Cleared Nov 23, 1999
EBI SPINELINK SYSTEM
K992920
Ebi, L.P.
Orthopedic · 85d
Cleared Nov 08, 1999
ISOBAR SEMI-RIGID SPINAL SYSTEM
K991326
Scien'Tx USA, Inc.
Orthopedic · 203d
Cleared Nov 08, 1999
ISOBAR SPINAL SYSTEM
K992738
Encore Orthopedics, Inc.
Orthopedic · 87d
Cleared Oct 13, 1999
SYNERGY INTEGRAL SCREWS, MODELS, 2161,2162,2163,2164,2165,2166,2167,2168,2169,2210,2211,2212,2215,2216,2217,2220,2221,22
K992369
Interpore Cross Intl.
Orthopedic · 90d
Cleared Oct 08, 1999
EBI OMEGA 21 SYSTEM
K992333
Electro-Biology, Inc.
Orthopedic · 87d