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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
Feb 5, 2007K062912SCIENT'X SPINAL SYSTEM
Scient'X
MNI
Jan 25, 2007K063601PILOT SPINAL SYSTEM
Life Spine
MNI
Jan 24, 2007K063794MODIFICATION TO EASYSPINE SYSTEM
Ldr Spine USA
MNI
Dec 22, 2006K062879TRAVERSE OCT SPINAL FIXATION SYSTEM
Medtronic Sofamor Danek, Inc.
MNI
Nov 16, 2006K062934SIERRA
Seaspine, Inc.
MNI
Oct 24, 2006K062853MODIFICATION TO STRYKER SPINE OASYS SYSTEM
Stryker Spine
MNI
Oct 11, 2006K062698TRIO + SPINAL SYSTEM
Stryker Spine
MNI
Oct 6, 2006K062136PASS 2 SPINAL SYSTEM
Medicrea
MNI
Sep 26, 2006K062505NEX-LINK SPINAL FIXATION SYSTEM OFFSET CONNECTORS, 2121-XX SERIES
Abbott Spine, Inc.
MNI
Sep 25, 2006K062606CD HORIZON SPINAL SYSTEM
Medtronic Sofamor Danek
MNI
Aug 22, 2006K061600ARX SPINAL SYSTEM
Life Spine
MNI
Aug 11, 2006K061978EBI, L.P.'S LINE EXTENSION TO THE ARRAY SPINAL SYSTEM
Ebi, L.P.
MNI
Aug 10, 2006K061017EASYSPINE SYSTEM
Ldr Spine USA
MNI
Jul 3, 2006K051704MYKRES SPINAL SYSTEM
Showa Ika Kohgyo Co., Ltd.
MNI
Mar 31, 2006K060634NEX-LINK SPINAL FIXATION SYSTEM ROD TO ROD CONNECTORS, MODELS 725, 726 SERIES
Abbott Spine, Inc.
MNI
Feb 3, 2006K060152MODIFICATION TO S4 SPINAL SYSTEM
Aesculap, Inc.
MNI
Jan 6, 2006K052566NEX-LINK SPINAL FIXATION SYSTEM OPEN POLYAXIAL SCREWS, MODELS 2112, 2113, 2118, 2119, 2120. NEX-LINK SPINAL FIXATION SY
Abbott Spine, Inc.
MNI
Jan 5, 2006K053483MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM
Medtronic Sofamor Danek
MNI
Dec 12, 2005K052847CAPLESS PEDICLE SCREW SYSTEM
X-Spine Systems, Inc.
MNI
Dec 7, 2005K052398MESA SPINAL SYSTEM
K2m, LLC
MNI
Dec 6, 2005K053115XIA SPINAL SYSTEM
Stryker Spine
MNI
Nov 16, 2005K052971STRYKER SPINE TRIO SPINAL FIXATION SYSTEM
Stryker Spine
MNI
Nov 7, 2005K052406UNI-THREAD SPINAL SYSTEM
Spine Vision, Inc.
MNI
Oct 11, 2005K052761MODIFICATION TO: XIA 4.5 SPINAL SYSTEM
Stryker Spine
MNI
Sep 21, 2005K052317MODIFICATION TO: STRYKER SPINE OASYS SYSTEM
Stryker Spine
MNI
Jul 27, 2005K050979S4 SPINAL SYSTEM
Aesculap, Inc.
MNI
May 23, 2005K051063POLYAXIAL HEMISPHERICAL SPINAL SCREWS
Scient'X
MNI
May 17, 2005K050981CD HORIZON SPINAL SYSTEM
Medtronic Sofamor Danek USA, Inc.
MNI
May 16, 2005K043484LANX SPINAL FIXATION SYSTEM
Lanx, LLC
MNI
May 4, 2005K050060LAGUNA PEDICLE SCREW SYSTEM
Allez Spine, LLC
MNI
Apr 11, 2005K050675EXPEDIUM SPINE SYSTEM SPINOUS PROCESS FUSION PLATE
Depuy Spine, Inc.
MNI
Feb 11, 2005K043094EASYSPINE SYSTEM
Ldr Spine USA
MNI
Nov 4, 2004K042210MSD SILO SPINAL SYSTEM
Medtronic Sofamor Danek
MNI
Oct 7, 2004K042514MODIFICATION TO BLACKSTONE MODULAR PEDICLE SCREW SYSTEM
Blackstone Medical, Inc.
MNI
Oct 7, 2004K042453MODIFICATION TO EQUATION FIXATION SYSTEM
Medtronic Sofamor Danek, Inc.
MNI
Sep 20, 2004K042100BLACKSTONE ASCENT POCT SYSTEM 5.5MM/3.0MM SINGLE AXIAL CONNECTOR
Blackstone Medical, Inc.
MNI
Sep 3, 2004K041777MODIFICATION TO CD HORIZON SPINAL SYSTEM
Medtronic Sofamor Danek
MNI
Sep 3, 2004K040493OUTOLOGOUS SPINAL FIXATION SYSTEM
Orthopedic Sciences, Inc.
MNI
Jul 1, 2004K033826ORTHOPEDIC ALLIANCE SPINE SYSTEM
Orthopedic Alliance, LLC
MNI
Jun 30, 2004K041030MODIFICATION TO CD HORIZON SPINAL SYSTEM
Medtronic Sofamor Danek
MNI
Jun 2, 2004K041203SUMMIT OCT SPINAL SYSTEM
Depuy Spine, Inc.
MNI
May 28, 2004K041118MODIFICATION TO CD HORIZON SPINAL SYSTEM
Medtronic Sofamor Danek
MNI
Mar 31, 2004K040583MODIFICATION TO: CD HORIZON SPINAL SYSTEM
Medtronic Sofamor Danek
MNI
Mar 12, 2004K040346MODIFICATION TO ORIA TOP CLIP SYSTEM
Ortho Tec, LLC
MNI
Mar 4, 2004K033947SHIRAZ POSTERIOR SYSTEM
Spine Next America
MNI
Mar 1, 2004K033150ART POSTERIOR SPINAL SYSTEM
Advanced Medical Technologies AG
MNI
Feb 25, 2004K033352VERTEBRON PSS PEDICLE SCREW SYSTEM
Vertebron, Inc.
MNI
Feb 20, 2004K032394STRYKER SPINE OASYS SYSTEM
Howmedica Osteonics Corp.
MNI
Feb 11, 2004K040034BLACKSTONE ASCENT POCT SYSTEM LATERAL OFFSET ADAPTER
Blackstone Medical, Inc.
MNI
Jan 27, 2004K033772SHIRAZ-JAVA SPINAL FIXATION SYSTEM
Spine Next America
MNI

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