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
121–144 of 303
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 16, 2000
SYNERGY VLS CAP NUT MODELS 2206, 6102
K000236
Interpore Cross Intl.
Orthopedic · 20d
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 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 Sep 21, 1999
CD HORIZON SPINAL SYSTEM
K992928
Sofamor Danek USA,Inc.
Orthopedic · 21d
Cleared Jun 28, 1999
SYNERGY ADJUSTABLE LENGTH ROD
K990057
Interpore Cross Intl.
Orthopedic · 172d
Cleared Mar 30, 1999
MODIFICATION TO SYNTHES UNIVERSAL SPINAL SYSTEM
K990745
Synthes Spine
Orthopedic · 22d
Cleared Mar 23, 1999
SYNERGY D2 SPINAL IMPLANTS
K984578
Interpore Cross Intl.
Orthopedic · 90d
Cleared Feb 01, 1999
OSTEONICS COMBINATION SCREW RING/BLOCKER
K990158
Osteonics Corp.
Orthopedic · 13d
Cleared Jan 28, 1999
OSTEONICS SPINAL SYSTEM-EXPANDED INDICATIONS
K990059
Howmedica Osteonics Corp.
Orthopedic · 20d
Cleared Jan 19, 1999
SYNTHES SPINE POSTERIOR UNIVERSAL SYSTEM
K984612
Synthes Spine
Orthopedic · 26d
Cleared Jan 06, 1999
MODIFICATION OF TSRH SPINAL SYSTEM
K984522
Danek Medical, Inc.
Orthopedic · 16d
Cleared Dec 30, 1998
DEPUY ACROMED MOSS SPINAL SYSTEM
K984378
Depuy, Inc.
Orthopedic · 23d
Cleared Dec 18, 1998
CD SPINAL SYSTEM
K980184
Sofamor Danek USA,Inc.
Orthopedic · 332d
Cleared Dec 16, 1998
DYNA-LOK SPINAL SYSTEM
K983672
Sofamor Danek USA,Inc.
Orthopedic · 58d
Cleared Oct 21, 1998
ISOLA SPINAL SYSTEM
K980485
Acromed Corp.
Orthopedic · 254d
Cleared Oct 21, 1998
SYNTHES POSTERIOR UNIVERSAL SPINAL SYSTEM
K982987
Synthes Spine
Orthopedic · 56d
Cleared Oct 21, 1998
TSRH SPINAL SYSTEM
K982990
Sofamor Danek USA,Inc.
Orthopedic · 56d
Cleared Oct 02, 1998
AESCULAP SPINE SYSTEM EVOLUTION
K980484
Aesculap, Inc.
Orthopedic · 235d
Cleared Oct 02, 1998
AESCULAP SPINE SYSTEM EVOLUTION: ADDITIONAL COMPONENTS
K982914
Aesculap, Inc.
Orthopedic · 44d
Cleared Aug 07, 1998
MODIFICATION TO TOWNLEY PEDICLE SCREW PLATING SYSTEM
K982686
Sofamor Danek USA,Inc.
Orthopedic · 4d