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NKB

905 FDA 510(k) clearances · Product code

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RecordFirmDate
Revolution Spinal Fixation System (K142939)Intelligent Implant Systems, LLC2015-01-13
PASS LP SPINAL SYSTEM (K141398)Medicrea International SA2015-01-09
Range/Denali/Mesa Spinal System (K143334)K2m, Inc.2015-01-09
Arsenal Spinal Fixation System (K143149)Alphatec Spine, Inc.2015-01-05
FIREBIRD SPINAL FIXATION SYSTEM (K141186)Orthofix, Inc.2015-01-02
ACROSSPINE PEDICLE SCREW SYSTEM (K141695)Arthro-Dif2014-12-30
Reform Pedicle Screw System (K143248)Precision Spine, Inc.2014-12-19
MAS PLIF Fixation system (K142737)Nu Vasive, Incorporated2014-12-18
Threshold Pedicular Fixation System (K143403)Spineology, Inc.2014-12-18
IBIS PEDICLE SCREW SYSTEM (K142146)Ortho Development Corp.2014-12-11
PGS 5.5 MM CANNULATED PEDICLE SCREW (K141282)Pinnacle Spine Group2014-12-02
CD HORIZON Spinal System (K143141)Medtronic Sofamor Danek USA, Inc.2014-12-01
CD HORIZON Spinal System (K142591)Medtronic Sofamor Danek USA, Inc.2014-12-01
EXPEDIUM VERSE SPINE SYSTEM (K142185)Depuy Spine, Inc.2014-11-19
Reline System (K142499)Nu Vasive, Incorporated2014-11-19
FLOSPINE PEDICLE SCREW SYSTEM (K141850)Flospine2014-10-27
CD HORIZON Spinal System (K142847)Medtronic Sofamor Danck USA, Inc.2014-10-27
CD HORIZON SPINAL SYSTEM (K141604)Medtronic Sofamor Danek USA, Inc.2014-10-21
Xia 3 Spinal System (K142381)Stryker Corp.2014-10-21
POLARIS SPINAL SYSTEM - HA COATED (K141804)Biomet Spine, LLC2014-09-25
RANGE/MESA/DENALI SPINAL SYSTEM (K141873)K2m, Inc.2014-09-08
VERTIFORM POSTERIOR FIXATION SYSTEM (K141291)Next Orthosurgical2014-08-26
MERCURY SPINAL SYSTEM (K141372)Spinal Elements, Inc.2014-08-22
M.U.S.T PEDICLE SCREW SYSTEM (K141988)Medacta International2014-08-19
M.U.S.T. EXTENSION (K141044)Medacta International2014-08-18
THUNDERBOLT AND LANCER PEDICLE SCREW SYSTEMS (K132049)Choicespine2014-08-15
CD HORIZON SPINAL SYSTEM (K141494)Medtronic Sofamor Danek USA, Inc.2014-08-06
K2M MODULAR HOOKS (K133402)K2m, Inc.2014-07-30
CD HORIZON SPINAL SYSTEM (K141605)Medtronic Sofamor Danek USA, Inc.2014-07-14
RANGE/MESA/DENALI SPINAL SYSTEM (K140765)K2m, Inc.2014-07-10
STERISPINE PS (K140802)Safe Orthopaedics2014-06-04
RANGE SPINAL SYSTEM (K141147)K2m, Inc.2014-06-03
EVEREST SPINAL SYSTEM (K140529)K2m, LLC2014-05-22
EXCELLA III-D SPINAL DEFORMITY SYSTEM (K140238)Innovasis, Inc.2014-05-07
POLARIS SPINAL SYSTEM -TRANSLATION SCREW (K140123)Ebi, LLC2014-04-24
FORTRESS PEDICLE SCREW SYSTEM (K140010)Spineology, Inc.2014-04-23
PICASSO II MIS SPINAL SYSTEM (K140219)Accel Spine2014-04-14
STREAMLINE TL SPINAL FIXATION SYSTEM (K140696)Pioneer Surgical Technology, Inc.2014-04-10
ORTHROS POSTERIOR STABILIZATION SYSTEM (K133366)Camber Spine2014-04-08
BAXANO SURGICAL MIS SPINAL SYSTEM (K133743)Baxano Surgical, Inc.2014-04-07
CD HORIZON SPINAL SYSTEM (K140449)Medtronic Sofamor Danek, Inc.2014-03-25
NAUTILUS SPINAL SYSTEM (K140457)Life Spine, Inc.2014-03-25
RANGE, SPINAL SYSTEM, EVEREST SPINAL SYSTEM (K133944)K2m, Inc.2014-03-21
ARSENAL SPINAL FIXATION SYSTEM (K133221)Alphatec Spine, Inc.2014-03-13
POLARIS SPINAL SYSTEM (K133746)Biomet Spine (Aka Ebi, LLC)2014-03-12
REVERE STABILIZATION SYSTEM (K133350)Globus Medical, Inc.2014-03-11
MODIFICATION TO NAUTILUS SPINAL SYSTEM (K133564)Life Spine, LLC2014-02-19
SAVANNAH-T, REDUCTION, SAVANNAH-T, HIGH-TOP, SAVANNAH-T, MONOAXIAL MID-TOP, SAVANNAH-T, LOW-TOP, SAVANNAH-LINK (K132925)Amendia, Inc.2014-02-11
TIGER SPINE SYSTEM (K133369)Corelink, LLC2014-01-14
SPINESELECT POLYSCREW PEDICLE SCREW SYSTEM (K133066)Spineselect, LLC2014-01-13
SANTIS PEDICLE SCREW SYSTEM (K133063)Lanterna Medical Technologies2014-01-13
M.U.S.T. EXTENSION (K132878)Medacta International2013-12-18
MANTIS & MANTIS REDUX SPINAL SYSTEM, RADIUS SPINAL SYSTEM, TRIO & TRIO+ SPINAL FIXATION SYSTEMS, AND TRIO TRAUMA SPINAL (K133188)Stryker Spine2013-12-17
ST360 DEGREES SPINAL FIXATION SYSTEM (K133291)Zimmer Spine, Inc.2013-12-17
CD HORIZON SPINAL SYSTEM (K132328)Medtronic Sofamor Danek USA, Inc.2013-12-06
TITLE 2 POLYAXIAL SPINAL SYSTEM (K133086)Zimmer Spine, Inc.2013-11-27
CD HORIZON SPINAL SYSTEM (K132639)Medtronic Sofamor Danek USA, Inc.2013-11-25
PATHFINDER NXT MINIMALLY INVASIVE PEDICLE SCREW SYSTEM (K132884)Zimmer Spine, Inc.2013-11-25
APEX SPINE SYSTEM (K132603)Spinecraft, LLC2013-11-20
GSB GLOBAL SPINAL BALANCE SYSTEM (K132014)Nuvasive, Inc.2013-10-31
NAUTILUS SPINAL SYSTEM (K132866)Life Spine, Inc.2013-10-28
CD HORIZON SPINAL SYSTEM (K132471)Medtronic Sofamor Danek USA, Inc.2013-10-08
NAUTILUS SPINAL SYSTEM (K132760)Life Spine, Inc.2013-10-03
TIGER SPINE SYSTEM (K131250)Corelink, LLC2013-09-10
SEQUOIA PEDICLE SCREW SYSTEM INCLUDING SPEEDLINK II TRANSVERSE CONNECTOR SYSTEM (K131980)Zimmer Spine, Inc.2013-09-04
LLIAD, KORA, ZENIUS PEDICLE SCREW SYSTEM (K131878)Medyssey USA, Inc.2013-08-23
PAGODA PEDICLE SCREW SYSTEM (K131785)Ortho Development Corp.2013-08-20
FIREBIRD SPINAL FIXATION SYSTEM (K130932)Orthofix, Inc.2013-08-07
CD HORIZON SPINAL SYSTEM (K132111)Medtronic Sofamor Danek USA2013-08-06
STREAMLINE TL SPINAL SYSTEM (K131100)Pioneer Surgical Technology, Inc.2013-06-27
EXPEDIUM SPINE SYSTEM (K130877)Medos International SARL2013-06-20
SOLANAS POSTERIOR STABILIZATION SYSTEM (K131119)Alphatec Spine, Inc.2013-05-21
STERISPINE PS PEDICLE SCREW (K130632)Safe Orthopaedics2013-05-03
INSTINCT JAVA SYSTEM (K123552)Zimmer Spine2013-04-19
S4 SPINAL SYSTEM (K130291)Aesculap Implant System, Inc.2013-04-11
CD HORIZON SPINAL SYSTEM (K130646)Medtronic Sofamor Danek USA, Inc.2013-04-10
STREAMLINE MIS SPINAL FIXATION SYSTEM (K130286)Pioneer Surgical Technology, Inc.2013-04-01
FIREBIRD SPINAL FIXATION SYSTEM (K130176)Orthofix2013-03-28
S4 SPINAL SYSTEM (K123939)Aesculap Implant Systems, Inc.2013-03-12
NAUTILUS SPINAL SYSTEM (K123373)Life Spine2013-03-06
UCENTUM (K123717)Ulrich GmbH & Co. KG2013-03-04
POLARIS SPINAL SYSTEM - BALLISTA II PERCUTANEOUS SCREW PLACEMENT SYSTEM (K123549)Biomet Spine (Aka Ebi, LLC)2013-02-25
CD HORIZON SPINAL SYSTEM (K123809)Medtronic Sofamor Danek USA, Inc.2013-02-22
ILLICO MIS POSTERIOR FIXATION SYSTEM (K123623)Alphatec Spine, Inc.2013-02-14
EASYSPINE SYSTEM (K123134)Ldr Spine USA, Inc.2013-02-01
MEDYSSEY CANNULATED PEDICLE SCREW (K121670)Medyssey Co, Ltd.2013-01-25
S4 SPINAL SYSTEM (K123352)Aesculap Implant Systems, Inc.2012-12-12
MALIBU SPINAL SYSTEM WITH THE DAYTONA DEFORMITY SYSTEM (K122571)Seaspine, Inc.2012-12-12
ES2 SPINAL SYSTEM MODEL 48280XXXX (K122845)Stryker Spine2012-12-07
POLARIS SPINAL SYSTEM - BALLISTA II RODS (K123451)Biomet Spine (Aka Ebi, LLC)2012-12-03
FIREBIRD SPINAL FIXATION SYSTEM, PHOENIX MIS SPINAL FIXATION SYSTEM (K122901)Orthofix2012-12-03
VICEROY SPINAL SYSTEM (K122229)Torrey Spine2012-11-20
CD HORIZON SPIRE Z SPINAL SYSTEM (K123246)Medtronic Sofamor Danek2012-11-16
DYMAXEON SPINE SYSTEM (K121786)B2b Spine Pty, Ltd.2012-11-05
TIGER SPINE SYSTEM (K121728)Corelink, LLC2012-10-05
CD HORIZON SPINAL SYSTEM (K122862)Medtronic Sofamor Danek USA, Inc.2012-10-03
REVERE STABILIZATION SYSTEM (K122226)Globus Medical, Inc.2012-10-01
TANGORS MULTIFUNCTIONAL POSTERIOR SYSTEM (K120891)Ulrich GmbH & Co. KG2012-10-01
CD HORIZON SPINAL SYSTEM (K122433)Medtronic Sofamor Danek, Inc.2012-09-28
DALI SPINAL FIXATION SYSTEM (K121568)Accel Spine2012-09-21
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