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905 FDA 510(k) clearances · Product code

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RecordFirmDate
CHOICE SPINE STARFIRE PEDICLE SCREW SYSTEM (K102204)Choicespine, LP2010-11-15
VIPER SPINE SYSTEM (K102701)Depuy Spine, Inc.2010-10-20
MODIFICATION TO:EXPEDIUM SPINE SYSTEM (K101933)Depuy Spine, Inc.2010-10-18
EXCELLA II SPINAL SYSTEM MODEL EC2-00 (K102248)Innovasis, Inc.2010-10-07
TSRH(R) SPINAL SYSTEM (K101772)Medtronic Sofamor Danek2010-09-30
CD HORIZON SPINAL SYSTEM (K091445)Medtronic Sofamor Danek2010-09-27
PATHFINDER II, MINIMALLY INVASIE PEDICLE SCREW SYSTEM MODEL 3500 SERIES (K100845)Zimmer Spine, Inc.2010-09-21
EXPEDIUM SPINE SYSTEM (K101070)Medos International SARL2010-08-31
MANTIS SPINAL SYSTEM & MANTIS REDUX SPINAL SYSTEM (K102235)Stryker Spine2010-08-24
STAINLESS STEEL SPINAL SYSTEM (K100970)Theken Spine, LLC2010-08-12
QUANTUM/ STREAMLINE SPINAL SYSTEM MODEL 02-SERIES AND 10-SERIES (K093692)Pioneer Surgical Technology2010-08-11
LANX SPINAL FIXATION SYSTEM (K100935)Lanx, Inc.2010-08-06
MODIFICATION TO SYNTHES MATRIX SYSTEM (K100952)Synthes Spine2010-08-05
FIREBIRD SPINAL FIXATION SYSTEM (K093926)Blackstone Medical, Inc.2010-07-28
S4 CERVICAL OCCIPITAL PLATE SPINAL SYSTEM (K100147)Aesculap Implant System, Inc.2010-07-23
MODIFICATION TO:RADIUS SPINAL SYSTEM (K101144)Stryker Spine2010-07-08
SYNTHES MATRIX SYSTEM (K100634)Synthes (Usa)2010-07-01
TILOCK PEDICLE SCREW SYSTEM (K100757)Genesys Spine2010-07-01
POLARIS SPINAL SYSTEM, POLARIS/SYNERGY STRUCTURE ANTERIOR FIXATION SYSTEM (K100438)Ebi, L.P.2010-06-23
POLARIS SPINAL SYSTEM, POLARIS/SYNERGY STRUCTUE ANTERIOR FIXATION SYSTEM (K100409)Biomet Spine (Aka Ebi, LLC)2010-06-23
MODIFICATION TO: CD HORIZON(R) SPINAL SYSTEM (K101074)Medtronic Sofamor Danek USA, Inc.2010-06-22
AESCULAP IMPLANT SYSTEMS S4 SPINAL SYSTEM (K100623)Aesculap Implant Systems2010-06-09
POLARIS SPINAL SYSTEM (K100220)Ebi, L.P.2010-05-17
COCR RODS (K100788)Globus Medical, Inc.2010-05-14
SPARTEK VARIABLE ANGLE PEDICLE SCREW POSTERIOR FUSION SYSTEM (K094002)Spartek Medical, Inc.2010-05-07
TSRH SPINAL SYSTEM (K091797)Medtronic Sofamor Danek2010-04-30
MODIFICATION TO: TRIO+SPINAL FIXATION SYSTEM (K100737)Stryker Spine2010-04-12
SYNTHES MATRIX MIS RODS (K093668)Synthes (Usa)2010-03-09
REVERE STABILIZATION SYSTEM (K093294)Globus Medical, Inc.2010-02-17
FIREBIRD SPINAL FIXATION SYSTEM, FIREBIRD SIDE-LOADING BODY (K100044)Blackstone2010-02-04
ANY PLUS SPINAL FIXATION SYSTEM (K091717)GS Medical Co., Ltd.2010-01-25
SYNTHES MATRIX SYSTEM (K092929)Synthes (Usa)2009-12-29
MODIFICATION TO:CD HORIZON SPINAL SYSTEM (K092325)Medtronic Sofamor Danek USA, Inc.2009-12-15
XIA 4.5 SPINAL SYSTEM (K092605)Stryker Spine2009-12-03
VERTEX RECONSTRUCTION SYSTEM AND VERTEX SELECT RECONSTRUCTION SYSTEM (K093434)Medtronic Sofamor Danek2009-12-02
EXPEDIUM SPINE SYSTEM (K092473)Depuy Spine, Inc.2009-11-25
CLAMPFIX (K090605)Synthes (Usa)2009-11-06
SPINAL FIXATION SYSTEM (K092536)Lanx, Inc.2009-10-30
TSRH SPINAL SYSTEM (K093058)Medtronic Sofamor Danek, Inc.2009-10-26
NUVASIVE SPHERX II - PEDICLE SCREW SYSTEM (K092287)Nuvasive, Inc.2009-10-06
TSRH SPINAL SYSTEM (K092676)Medtronic Sofamor Danek, Inc.2009-10-02
MODIFICATION TO: EXPEDIUM SPINE SYSTEM (K092626)Depuy Spine, Inc.2009-09-25
MANTIS REDUX SPINAL SYSTEM (K092631)Stryker Spine2009-09-25
FIREBIRD SPINAL FIXATION SYSTEM (K092624)Blackstone Medical, Inc.2009-09-25
MODIFICATION TO BEACON STABILIZATION SYSTEM (K092610)Globus Medical, Inc.2009-09-24
MODIFICATION TO CD HORIZON SPINAL SYSTEM (K091974)Medtronic Sofamor Danek USA, Inc.2009-09-02
MODIFICATION TO: TSRH SPINAL SYSTEM (K090740)Medtronic Sofamor Danek2009-08-14
REVERE 6.35 STABILIZATION SYSTEM (K091782)Globus Medical, Inc.2009-08-13
MONOPOLY PEDICLE SCREW SYSTEM (K092073)Signus Medical2009-08-07
LAGUNA SIZE 8 PEDICLE SCREW SYSTEM (K091995)Allez Spine, LLC2009-08-07
TI-TAMED SPINAL SYSTEM (K070385)Ti-Tamed (Pty), Ltd.2009-07-31
5.5 HELICAL FLANGE SPINAL SYSTEM, POLARIS COMPONENTS (K090203)Ebi, L.P.2009-07-30
CONQUEST SPINAL SYSTEM (K090320)Life Spine2009-07-22
NUVASIVE SPHERX II SYSTEM (K091502)Nuvasive, Inc.2009-07-22
CD HORIZON SPINAL SYSTEM (K091442)Medtronic Sofamor Danek2009-07-15
5.5 POLARIS SPINAL SYSTEM (K091067)Biomet Spine2009-07-14
DEL MAR MONOAXIAL PEDICLE SCREW SYSTEM (K091219)Allez Spine, LLC2009-07-09
MODIFICATION TO: NUVASIVE SPHERX SYSTEM (K090981)Nuvasive, Inc.2009-07-02
MILI (MINIMALLY INVASIVE LUMBAR IMPLANT) SYSTEM (K083004)Aesculap Implant Systems, Inc.2009-07-02
POLARIS SPINAL SYSTEM (K090523)Ebi, L.P.2009-07-01
MERCURY SPINAL SYSTEM (K091587)Spinal Elements, Inc.2009-07-01
XIA 3 SPINAL SYSTEM, UNIPLANNER/REDUCTION SCREWS & VITALLIUM ROD (K091291)Stryker Spine2009-06-24
DSS STABILIZATION SYSTEM (K090099)Paradigm Spine, LLC2009-06-19
VIPER 2 SYSTEM (K090648)Depuy Spine, Inc.2009-06-10
THEKEN CORAL SPINAL SYSTEM (K091266)Theken Spine, LLC2009-06-10
CD HORIZON SPINAL SYSTEM (K090390)Medtronic Sofamor Danek2009-05-15
MODIFICATION TO EXPEDIUM SPINE SYSTEM (K090799)Depuy Spine, Inc.2009-04-22
MODIFICATION TO: S4 SPINAL SYSTEM (K090657)Aesculap Implant Systems2009-04-20
XIA 3 SPINAL SYSTEM (K083393)Stryker Spine2009-04-01
MODIFICATION TO: DSS STABILIZATION SYSTEM (K090408)Paradigm Spine, LLC2009-03-20
EOI SPINAL SYSTEM (K083825)Expanding Orthopedics, Inc.2009-03-19
EXPEDIUM SPINE SYSTEM (K090230)Depuy Spine, Inc.2009-03-06
MERCURY SPINAL SYSTEM (K082353)Spinal Elements, Inc.2009-01-22
NEWPORT SPINAL SYSTEM (K083089)Seaspine, Inc.2009-01-13
REVOLVE STABILIZATION SYSTEM (K083416)Globus Medical, Inc.2009-01-09
CLAMPFIX (K082914)Synthes Spine2008-12-11
MERCURY SPINAL SYSTEM (K083230)Spinal Elements, Inc.2008-12-03
USS ILIOSACRAL, USS POLYAXIAL (K082572)Synthes Spine2008-11-24
TSRH SPINAL SYSTEM (K081080)Medtronic Sofamor Danek2008-11-21
MODIFICATION TO: NUVASIVE SPHERX II SYSTEM (K083028)Nuvasive, Inc.2008-11-13
MODFICATION TO: EXPEDIUM SPINE SYSTEM (K082942)Depuy Spine, Inc.2008-10-31
BLACKSTONE PEDICLE SCREW SYSTEM (K082797)Blackstone Medical, Inc.2008-10-17
CD HORIZON SPINAL SYSTEM (K082236)Medtronic Sofamor Danek2008-10-10
NUVASIVE SPHERX SYSTEM (K082332)Nuvasive, Inc.2008-10-10
LDR SPINE EASYSPINE SYSTEM (K082592)Ldr Spine USA2008-10-08
RADIUS SPINAL SYSTEM, VITALLIUM ROD #486613601 (K082608)Stryker Spine2008-10-07
SYNERGY SPINAL SYSTEM (6.35 POLARIS) (K081952)Biomet Spine2008-10-07
SEQUOIA SPINAL SYSTEM (MODEL 3306), SPEEDLINK TRANSVERSE CONNECTOR (MODELS 3308, 3309, 3310) (K082032)Abbott Spine, Inc.2008-10-06
BLACKSTONE PEDICLE SCREW SYSTEM (K081684)Blackstone Medical, Inc.2008-09-15
EXPEDIUM SPINE SYSTEM (K081898)Depuy Spine, Inc.2008-09-10
MODIFICATIONS TO EXPEDIUM SPINE SYSTEM (K082195)Depuy Spine, Inc.2008-09-03
MONOPOLY PEDICLE SCREW SYSTEM (K081108)Signus Medical, LLC2008-07-14
LAGUNA SIZE 8 PEDICLE SCREW (K072678)Allez Spine, LLC2008-07-02
MODIFICATION TO CORAL SPINAL SYSTEM (K081414)Theken Spine, LLC2008-06-17
AXIS FIXATION SYSTEM (K062254)Medtronic Sofamor Danek, Inc.2008-06-16
EXPEDIUM 4.5MM SPINE SYSTEM (K081252)Depuy Spine, Inc.2008-05-30
REVERE UNIPLANAR SCREWS (K081195)Globus Medical, Inc.2008-05-28
MODIFICATION TO VIPER SPINE SYSTEM (K073562)Depuy Spine, Inc.2008-05-15
MODIFICATION TO EXPEDIUM SPINE SYSTEM (K080313)Depuy Spine, Inc.2008-05-08
XIA SPINAL SYSTEM, STAINLESS STEEL UNI-PLANAR SCREWS (K080928)Stryker Spine2008-04-30
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