ClearanceBrief
Panels › Orthopedic › Product code MNI · Class 2

Orthosis, Spinal Pedicle Fixation

Regulation 888.3070

0510(k)s in 12 months (303 all time)
1recalls in 12 months (213 all time)
212recalls that name a 510(k)
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Top companies in MNI

Company510(k)sRecalls
Valorem Surgical LLC0144
Allez Spine, LLC127
Medtronic Sofamor Danek250
K2m, Inc.150
Spine Wave, Inc.110
Blackstone Medical, Inc.73
Stryker Spine72
Spinal USA80
Spinal Solutions, LLC08
Life Spine70
Decided510(k)Device and applicantCode
Jun 6, 2001K011437SYNERGY 4.0 MM, 4.5 MM VLS SCREWS
Interpore Cross Intl.
MNI
Jun 6, 2001K010922TRI-FIX SPINAL FIXATION SYSTEM
Endius, Inc.
MNI
Jun 6, 2001K010903TRI-FIX SPINAL FIXATION SYSTEM
Endius, Inc.
MNI
Jun 6, 2001K010108USS-LINE EXTENSION
Synthes
MNI
Jun 5, 2001K011029MODIFICATION TO TSRH SPINAL SYSTEM
Medtronic Sofamor Danek, Inc.
MNI
Jun 4, 2001K010658MODIFIED USS FRACTURE SYSTEM
Synthes (Usa)
MNI
May 25, 2001K010563END-TO-END AND SIDE-BY-SIDE CONNECTORS
Spinal Concepts, Inc.
MNI
May 23, 2001K010576MONARCH SPINE SYSTEM
Depuyacromed
MNI
May 8, 2001K003735BLACKSTONE SPINAL FIXATION SYSTEM, SECOND-GENERATION CROSS-CONNECTOR
Blackstone Medical, Inc.
MNI
May 4, 2001K011067MODIFICATION TO TSRH SPINAL SYSTEM
Medtronic Sofamor Danek, Inc.
MNI
Oct 17, 2000K994121SMALL STATURE USS
Synthes (Usa)
MNI
Jun 1, 2000K000766TRI-FIX SPINAL FIXATION SYSTEM
Endius, Inc.
MNI
May 11, 2000K000965MULTI-AXIAL CROSS (MAC) CONNECTOR
Howmedica Osteonics Corp.
MNI
Apr 18, 2000K000991MODIFICATION TO TSRH SPINAL SYSTEM
Medtronic Sofamor Danek, Inc.
MNI
Apr 18, 2000K000876SYNERGY ADJUSTABLE TRANSVERSE CONNECTOR ROD, SYNERGY ADJUSTABLE TRANSVERSE CONNECTOR LAMP
Interpore Cross Intl.
MNI
Apr 14, 2000K001037MODIFICATION TO EBI SPINELINK SYSTEM
Ebi, L.P.
MNI
Mar 10, 2000K000450MODIFICATION TO SYNTHES USS
Synthes Spine
MNI
Mar 7, 2000K000425ISOBAR SPINAL SYSTEM
Encore Orthopedics, Inc.
MNI
Feb 28, 2000K992147TRIPLE-FIX SPINAL FIXATION SYSTEM
Advanced Spine Technology, Inc.
MNI
Feb 16, 2000K000236SYNERGY VLS CAP NUT MODELS 2206, 6102
Interpore Cross Intl.
MNI
Jan 13, 2000K991862MICOMED POSTERIOR DOUBLEROD SYSTEM (MPDS)
Micomed GmbH
MNI
Dec 20, 1999K993402OPUS SPINAL SYSTEM
Howmedica Osteonics Corp.
MNI
Nov 23, 1999K992920EBI SPINELINK SYSTEM
Ebi, L.P.
MNI
Nov 8, 1999K992738ISOBAR SPINAL SYSTEM
Encore Orthopedics, Inc.
MNI
Nov 8, 1999K991326ISOBAR SEMI-RIGID SPINAL SYSTEM
Scien'Tx USA, Inc.
MNI
Oct 13, 1999K992369SYNERGY INTEGRAL SCREWS, MODELS, 2161,2162,2163,2164,2165,2166,2167,2168,2169,2210,2211,2212,2215,2216,2217,2220,2221,22
Interpore Cross Intl.
MNI
Oct 8, 1999K992333EBI OMEGA 21 SYSTEM
Electro-Biology, Inc.
MNI
Oct 1, 1999K992276MODIFICATION TO SILHOUETTE SPINAL FIXATION SYSTEM
Sulzer Spine-Tech
MNI
Sep 21, 1999K992928CD HORIZON SPINAL SYSTEM
Sofamor Danek USA,Inc.
MNI
Aug 13, 1999K991721EBI OMEGA 21 SYSTEM
Ebi Electro Biology
MNI
Jun 28, 1999K990057SYNERGY ADJUSTABLE LENGTH ROD
Interpore Cross Intl.
MNI
Mar 30, 1999K990745MODIFICATION TO SYNTHES UNIVERSAL SPINAL SYSTEM
Synthes Spine
MNI
Mar 23, 1999K984578SYNERGY D2 SPINAL IMPLANTS
Interpore Cross Intl.
MNI
Feb 1, 1999K990158OSTEONICS COMBINATION SCREW RING/BLOCKER
Osteonics Corp.
MNI
Jan 28, 1999K990059OSTEONICS SPINAL SYSTEM-EXPANDED INDICATIONS
Howmedica Osteonics Corp.
MNI
Jan 20, 1999K984350VSP SYSTEM
Depuy Motech Acromed
MNI
Jan 20, 1999K984348TIMX LOW BACK SYSTEM
Depuy Motech Acromed
MNI
Jan 19, 1999K984612SYNTHES SPINE POSTERIOR UNIVERSAL SYSTEM
Synthes Spine
MNI
Jan 19, 1999K984027EBI SPINELINK SYSTEM
Electro-Biology, Inc.
MNI
Jan 6, 1999K984522MODIFICATION OF TSRH SPINAL SYSTEM
Danek Medical, Inc.
MNI
Dec 30, 1998K984378DEPUY ACROMED MOSS SPINAL SYSTEM
Depuy, Inc.
MNI
Dec 18, 1998K980184CD SPINAL SYSTEM
Sofamor Danek USA,Inc.
MNI
Dec 16, 1998K983672DYNA-LOK SPINAL SYSTEM
Sofamor Danek USA,Inc.
MNI
Oct 21, 1998K983260MODIFICATION TO SPINAL CONCEPTS BACFIX TI SPINAL FIXATION SYSTEM
Spinal Concepts, Inc.
MNI
Oct 21, 1998K983258MODIFICATION TO SPINAL CONCEPTS BACFIX SPINAL FIXATION SYSTEM
Spinal Concepts, Inc.
MNI
Oct 21, 1998K982990TSRH SPINAL SYSTEM
Sofamor Danek USA,Inc.
MNI
Oct 21, 1998K982987SYNTHES POSTERIOR UNIVERSAL SPINAL SYSTEM
Synthes Spine
MNI
Oct 21, 1998K980485ISOLA SPINAL SYSTEM
Acromed Corp.
MNI
Oct 2, 1998K982914AESCULAP SPINE SYSTEM EVOLUTION: ADDITIONAL COMPONENTS
Aesculap, Inc.
MNI
Oct 2, 1998K980484AESCULAP SPINE SYSTEM EVOLUTION
Aesculap, Inc.
MNI

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