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MNI

303 FDA 510(k) clearances · Product code

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RecordFirmDate
ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM (K090779)Alphatec Spine, Inc.2009-07-07
INERTIA PEDICLE SCREW SYSTEM (K090984)Nexxt Spine, LLC2009-06-30
MODIFICATION TO: PSS SYSTEM (K090033)Spinal USA2009-05-06
THEKEN ATOLL OCT SPINAL SYSTEM (K083863)Theken Spine, LLC2009-03-27
RELIANCE SPINAL SCREW SYSTEM (K081978)Reliance Medical Systems, LLC2009-03-26
THEKEN ATOLL CERVICO-THORACIC SYSTEM (K083073)Theken Spine, LLC2009-03-13
SOLAS ANATOMIX SPINAL SYSTEM (K083178)Biotechni America Spine Group, Inc.2009-02-23
PILOT SPINAL SYSTEM (K083865)Life Spine2009-01-28
TRAUSON GENERAL SPINAL SYSTEM (GSS) (K082617)Trauson (Jiangsu) Medical Instrument Co., Ltd.2009-01-15
CAPSURE PS SYSTEM (K083743)Spine Wave, Inc.2009-01-13
CAPSURE(R) PS SYSTEM (K083353)Spine Wave, Inc.2008-12-11
PASS LP SPINAL SYSTEM (K083308)Medicrea Technologies2008-12-10
MODIFICATION TO 4CIS VANE SPINE SYSTEM (K081145)Solco Biomedical Co., Ltd.2008-11-05
PASS 2 SPINAL SYSTEM (K082069)Medicrea Technologies2008-10-03
MODIFICATION TO SINGLE PLANAR MULTI AXIS (SPMA) PEDICLE SCREW SYSTEM (K081790)Trinity Orthopedics, LLC2008-07-24
COSMIC SYSTEM (K080841)Ulrich GmbH & Co. KG2008-07-23
ZODIC POLYAXIAL SPINAL FIXATION SYSTEM (K081158)Alphatec Spine, Inc.2008-07-03
ORTHOBIOM SPINAL SYSTEM (K071668)Paradigm Spine2008-07-02
MYKRES SPINAL SYSTEM (K071074)Showa Ika Kohgyo Co., Ltd.2008-07-02
MODIFICATION TO VERTEBRON PSS PEDICLE SCREW SYSTEM (K081597)Vertebron, Inc.2008-07-02
CONQUEST SPINAL SYSTEM (K080767)Life Spine2008-05-21
CAPSURE PS (R) SPINE SYSTEM (K081228)Spine Wave, Inc.2008-05-12
PASS SPINAL SYSTEM (K080099)Medicrea Technologies2008-04-09
K2M COCR ROD (K080792)K2m, Inc.2008-04-08
MODIFICATION TO:PILOT SPINAL SYSTEM (K080502)Life Spine2008-04-08
MODIFIED VERTIFLEX SPINAL SCREW SYSTEM (K073143)Vertiflex, Inc.2008-04-07
PSS SYSTEM (K073240)Spinal USA2008-03-20
BLACKSTONE SFS PARALLEL ROD CONNECTORS (K080407)Blackstone Medical, Inc.2008-03-13
MODIFICATION TO STRYKER SPINE OASYS SYSTEM (K080143)Stryker Spine2008-02-14
QUANTUM-MIS CANNULATED SYSTEM (K080026)Pioneer Surgical Technology2008-01-28
MODIFICATION TO: VERTEFIX PEDICLE SCREW SPINAL SYSTEM (K080075)Elite Surgical Supplies (Pty), Ltd.2008-01-28
SYNTHES OC FUSION AND SYNAPSE SYSTEMS (K072434)Synthes Spine Co.Lp2008-01-10
NATURAL BRIDGE LP TRANSVERSE CONNECTORS (K072914)K2m, Inc.2008-01-03
MEGA SPINE SYSTEM (K072436)Bk Meditech, Co., Ltd.2007-11-01
PIONEER LOWTOP SPINAL ROD SYSTEM (K072187)Pioneer Surgical Technology2007-10-12
Optima ZS Transition Screw (K071880)Zimmer Spine, Inc.2007-10-05
MODIFICATION TO PASSMED SPINAL SYSTEM (K070276)Medicrea Technologies2007-09-21
LANX SPINAL FIXATION SYSTEM (K071877)Lanx, LLC2007-09-17
ACME TALON PEDICLE SCREW (K071824)Acme Spine, LLC2007-09-04
VERTEFIX PEDICLE SCREW SPINAL SYSTEM (K063453)Elite Surgical Supplies (Pty), Ltd.2007-08-30
PSS SYSTEM (K071438)Spinal USA2007-08-21
DELTA SPINAL FUSION SYSTEM (K071857)Jemo Spine, LLC2007-08-08
NUVASIVE OCT SYSTEM (K071435)Nuvasive, Inc.2007-08-06
PILLAR PEDICLE SCREW SYSTEM (K071743)The 4th Column, LLC2007-07-06
SYNAPSE SYSTEM (K070573)Synthes Spine Co.Lp2007-06-08
SINGLE PLANAR MULTI AXIAL (SPMA) PEDICLE SCREW SYSTEM (K070295)Trinity Orthopedics, LLC2007-05-21
ROC LUMBAR SYSTEM (K063668)Alphatec Spine, Inc.2007-05-18
RANGE SPINAL SYSTEM (K070229)K2m, Inc.2007-05-03
4S SPINAL SYSTEM (K063708)Taeyeon Medical Co., Ltd.2007-04-24
CAPSURE PEDICLE SCREW SYSTEM (K070245)Spine Wave, Inc.2007-04-05
SCIENT'X SPINAL SYSTEM (K062912)Scient'X2007-02-05
PILOT SPINAL SYSTEM (K063601)Life Spine2007-01-25
MODIFICATION TO EASYSPINE SYSTEM (K063794)Ldr Spine USA2007-01-24
TRAVERSE OCT SPINAL FIXATION SYSTEM (K062879)Medtronic Sofamor Danek, Inc.2006-12-22
SIERRA (K062934)Seaspine, Inc.2006-11-16
MODIFICATION TO STRYKER SPINE OASYS SYSTEM (K062853)Stryker Spine2006-10-24
TRIO + SPINAL SYSTEM (K062698)Stryker Spine2006-10-11
PASS 2 SPINAL SYSTEM (K062136)Medicrea2006-10-06
NEX-LINK SPINAL FIXATION SYSTEM OFFSET CONNECTORS, 2121-XX SERIES (K062505)Abbott Spine, Inc.2006-09-26
CD HORIZON SPINAL SYSTEM (K062606)Medtronic Sofamor Danek2006-09-25
ARX SPINAL SYSTEM (K061600)Life Spine2006-08-22
EBI, L.P.'S LINE EXTENSION TO THE ARRAY SPINAL SYSTEM (K061978)Ebi, L.P.2006-08-11
EASYSPINE SYSTEM (K061017)Ldr Spine USA2006-08-10
MYKRES SPINAL SYSTEM (K051704)Showa Ika Kohgyo Co., Ltd.2006-07-03
NEX-LINK SPINAL FIXATION SYSTEM ROD TO ROD CONNECTORS, MODELS 725, 726 SERIES (K060634)Abbott Spine, Inc.2006-03-31
MODIFICATION TO S4 SPINAL SYSTEM (K060152)Aesculap, Inc.2006-02-03
NEX-LINK SPINAL FIXATION SYSTEM OPEN POLYAXIAL SCREWS, MODELS 2112, 2113, 2118, 2119, 2120. NEX-LINK SPINAL FIXATION SY (K052566)Abbott Spine, Inc.2006-01-06
MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM (K053483)Medtronic Sofamor Danek2006-01-05
CAPLESS PEDICLE SCREW SYSTEM (K052847)X-Spine Systems, Inc.2005-12-12
MESA SPINAL SYSTEM (K052398)K2m, LLC2005-12-07
XIA SPINAL SYSTEM (K053115)Stryker Spine2005-12-06
STRYKER SPINE TRIO SPINAL FIXATION SYSTEM (K052971)Stryker Spine2005-11-16
UNI-THREAD SPINAL SYSTEM (K052406)Spine Vision, Inc.2005-11-07
MODIFICATION TO: XIA 4.5 SPINAL SYSTEM (K052761)Stryker Spine2005-10-11
MODIFICATION TO: STRYKER SPINE OASYS SYSTEM (K052317)Stryker Spine2005-09-21
S4 SPINAL SYSTEM (K050979)Aesculap, Inc.2005-07-27
POLYAXIAL HEMISPHERICAL SPINAL SCREWS (K051063)Scient'X2005-05-23
CD HORIZON SPINAL SYSTEM (K050981)Medtronic Sofamor Danek USA, Inc.2005-05-17
LANX SPINAL FIXATION SYSTEM (K043484)Lanx, LLC2005-05-16
LAGUNA PEDICLE SCREW SYSTEM (K050060)Allez Spine, LLC2005-05-04
EXPEDIUM SPINE SYSTEM SPINOUS PROCESS FUSION PLATE (K050675)Depuy Spine, Inc.2005-04-11
EASYSPINE SYSTEM (K043094)Ldr Spine USA2005-02-11
MSD SILO SPINAL SYSTEM (K042210)Medtronic Sofamor Danek2004-11-04
MODIFICATION TO EQUATION FIXATION SYSTEM (K042453)Medtronic Sofamor Danek, Inc.2004-10-07
MODIFICATION TO BLACKSTONE MODULAR PEDICLE SCREW SYSTEM (K042514)Blackstone Medical, Inc.2004-10-07
BLACKSTONE ASCENT POCT SYSTEM 5.5MM/3.0MM SINGLE AXIAL CONNECTOR (K042100)Blackstone Medical, Inc.2004-09-20
OUTOLOGOUS SPINAL FIXATION SYSTEM (K040493)Orthopedic Sciences, Inc.2004-09-03
MODIFICATION TO CD HORIZON SPINAL SYSTEM (K041777)Medtronic Sofamor Danek2004-09-03
ORTHOPEDIC ALLIANCE SPINE SYSTEM (K033826)Orthopedic Alliance, LLC2004-07-01
MODIFICATION TO CD HORIZON SPINAL SYSTEM (K041030)Medtronic Sofamor Danek2004-06-30
SUMMIT OCT SPINAL SYSTEM (K041203)Depuy Spine, Inc.2004-06-02
MODIFICATION TO CD HORIZON SPINAL SYSTEM (K041118)Medtronic Sofamor Danek2004-05-28
MODIFICATION TO: CD HORIZON SPINAL SYSTEM (K040583)Medtronic Sofamor Danek2004-03-31
MODIFICATION TO ORIA TOP CLIP SYSTEM (K040346)Ortho Tec, LLC2004-03-12
SHIRAZ POSTERIOR SYSTEM (K033947)Spine Next America2004-03-04
ART POSTERIOR SPINAL SYSTEM (K033150)Advanced Medical Technologies AG2004-03-01
VERTEBRON PSS PEDICLE SCREW SYSTEM (K033352)Vertebron, Inc.2004-02-25
STRYKER SPINE OASYS SYSTEM (K032394)Howmedica Osteonics Corp.2004-02-20
BLACKSTONE ASCENT POCT SYSTEM LATERAL OFFSET ADAPTER (K040034)Blackstone Medical, Inc.2004-02-11
PLUS PIVOT LINK UNIVERSAL SYSTEM (K033508)Spine Vision, Inc.2004-01-27
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