NuVasive Armada™ rods (CoCr)

국가: 싱가포르

언어: 영어

출처: HSA (Health Sciences Authority)

제공처:

NUVASIVE SOUTHEAST ASIA PTE. LTD.

수업:

Class C medical device

Manufactured by:

Nuvasive Inc

치료 영역:

Orthopaedics

치료 징후:

The Armada rods when used with the compatible constituent components as a pedicle screw fixation system, is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the posterior thoracic, lumbar, and sacral spine. Indications: 1. Degenerative disc disease 2. Degenerative spondylolisthesis with objective evidence of neurologic impairment 3. Fracture 4. Dislocation 5. Scoliosis 6. Kyphosis 7. Spinal tumor and/or 8. Failed previous fusion (pseudoarthrosis). It is also indicated for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebral joint in skeletally mature patients receiving fusion by autogenous bone graft, having the device fixed or attached to the lumbar and sacral spine (L3 to sacrum), with removal of the implants after attainment of a solid fusion. The rods when used with the compatible constituent components as an anterol

제품 요약:

Device System Info:[System or Procedure Pack], It consisted of the rods and instruments.; Models: 5.5MM ARMADA COCR ROD, 15MM - 8252015, 5.5MM ARMADA COCR ROD, 20MM - 8252020, 5.5MM ARMADA COCR ROD, 25MM - 8252025, 5.5MM ARMADA COCR ROD, 30MM - 8252030, 5.5MM ARMADA COCR ROD, 35MM - 8252035, 5.5MM ARMADA COCR ROD, 40MM - 8252040, 5.5MM ARMADA COCR ROD, 45MM - 8252045, 5.5MM ARMADA COCR ROD, 50MM - 8252050, 5.5MM ARMADA COCR ROD, 55MM - 8252055, 5.5MM ARMADA COCR ROD, 60MM - 8252060, 5.5MM ARMADA COCR ROD, 65MM - 8252065, 5.5MM ARMADA COCR ROD, 70MM - 8252070, 5.5MM ARMADA COCR ROD, 75MM - 8252075, 5.5MM ARMADA COCR ROD, 80MM - 8252080, 5.5MM ARMADA COCR ROD, 85MM - 8252085, 5.5MM ARMADA COCR ROD, 90MM - 8252090, 5.5MM ARMADA COCR ROD, 95MM - 8252095, 5.5MM ARMADA COCR ROD, 100MM - 8252100, 5.5MM ARMADA COCR ROD, 105MM - 8252105, 5.5MM ARMADA COCR ROD, 110MM - 8252110, 5.5MM ARMADA COCR ROD, 115MM - 8252115, 5.5MM ARMADA COCR ROD, 120MM - 8252120, 5.5MM ARMADA COCR ROD, 125MM - 8252125, 5.5MM ARMADA COCR ROD, 130MM - 8252130, 5.5MM ARMADA COCR ROD, 135MM - 8252135, 5.5MM ARMADA COCR ROD, 140MM - 8252140, 5.5MM ARMADA COCR ROD, 145MM - 8252145, 5.5MM ARMADA COCR ROD, 150MM - 8252150, 5.5MM ARMADA COCR ROD, 155MM - 8252155, 5.5MM ARMADA COCR ROD, 160MM - 8252160, 5.5MM ARMADA COCR ROD, 165MM - 8252165, 5.5MM ARMADA COCR ROD, 170MM - 8252170, 5.5MM ARMADA COCR ROD, 175MM - 8252175, 5.5MM ARMADA COCR ROD, 180MM - 8252180, 5.5MM ARMADA COCR ROD, 185MM - 8252185, 5.5MM ARMADA COCR ROD, 190MM - 8252190, 5.5MM ARMADA COCR ROD, 195MM - 8252195, 5.5MM ARMADA COCR ROD, 200MM - 8252200, 5.5MM ARMADA COCR ROD, 210MM - 8252210, 5.5MM ARMADA COCR ROD, 220MM - 8252220, 5.5MM ARMADA COCR ROD, 230MM - 8252230, 5.5MM ARMADA COCR ROD, 240MM - 8252240, 5.5MM ARMADA COCR ROD, 250MM - 8252250, 5.5MM ARMADA COCR ROD, 260MM - 8252260, 5.5MM ARMADA COCR ROD, 270MM - 8252270, 5.5MM ARMADA COCR ROD, 280MM - 8252280, 5.5MM ARMADA COCR ROD, 290MM - 8252290, 5.5MM ARMADA COCR ROD, 300MM - 8252300, 5.5MM ARMADA COCR ROD, 310MM - 8252310, 5.5MM ARMADA COCR ROD, 320MM - 8252320, 5.5MM ARMADA COCR ROD, 330MM - 8252330, 5.5MM ARMADA COCR ROD, 340MM - 8252340, 5.5MM ARMADA COCR ROD, 350MM - 8252350, 5.5MM ARMADA COCR ROD, 360MM - 8252360, 5.5MM ARMADA COCR ROD, 370MM - 8252370, 5.5MM ARMADA COCR ROD, 380MM - 8252380, 5.5MM ARMADA COCR ROD, 390MM - 8252390, 5.5MM ARMADA COCR ROD, 400MM - 8252400, 5.5MM ARMADA COCR ROD, 450MM - 8252450, 5.5MM ARMADA COCR ROD, 500MM - 8252500, 5.5MM ARMADA COCR ROD, 600MM - 8252600, AWL - 7451001, NARROW AWL - 7451002, NARROW GEARSHIFT PROBE, STRAIGHT - 7451003, NARROW GEARSHIFT PROBE, CURVED - 7451004, GEARSHIFT PROBE, STRAIGHT - 7451005, GEARSHIFT PROBE, CURVED - 7451006, BALL TIP PEDICLE PROBE, STRAIGHT - 7451007, BALL TIP PEDICLE PROBE, CURVED - 7451008, KERRISON PERSUADER - 7451009, ROCKER - 7451010, REDUCTION TOWER 6.25/PLS - 7451011, REDUCTION TOWER T-HANDLE - 7451012, REDUCTION SCREW BREAK OFF TOOL - 7451013, POLYAXIAL SCREWDRIVER, 6.25MM/PLS - 7451014, SELF-RETAINING SCREWDRIVER 6.25MM/PLS - 7451015, SCREW ADJUSTER - 7451016, COUNTER-TORQUE - 7451017, TORQUE T-HANDLE - 7451018, ROD PUSHER, 5.5MM ROD - 7451019, LOCK SCREW GUIDE/DEROTATION TOWER - 7451020, LOCK SCREW STARTER 6.25MM/PLS - 7451021, LOCK SCREW STARTER, STRAIGHT 6.25MM/PLS - 7451022, LOCK SCREW DRIVER 6.25MM/PLS - 7451023, ROD HOLDER, 5.5MM ROD - 7451024, ROD GRIPPER, 6.25MM ROD - 7451025, ROD GRIPPER, 5.5MM ROD - 7451026, ROD TEMPLATE, 5.5MM - 7451027, ROD TEMPLATE, 6.25MM - 7451028, IN-SITU SAGITTAL BENDER, 5.5MM ROD, L - 7451029, IN-SITU SAGITTAL BENDER, 5.5MM ROD, R - 7451030, IN SITU CORONAL BENDERS, 5.5MM - 7451031, IN-SITU CORONAL BENDER, RIGHT - 7451032, ROD ROTATION WRENCH - 7451033, ROD TO ROD ELEVATOR 5.5MM ROD - 7451034, TABLETOP ROD BENDER - 7451035, FRENCH BENDER - 7451036, PLATE STYLE BENDER LEFT - 7451037, IN-SITU ROD CUTTER - 7451038, TABLETOP ROD CUTTER - 7451039, IMPLANT HOLDER, 6.25MM/PLS - 7451040, PARALLEL COMPRESSOR - 7451041, COMPRESSOR, SINGLE ACTION - 7451042, PARALLEL DISTRACTOR - 7451043, DISTRACTOR, SINGLE ACTION - 7451044, CROSS CONNECTOR MEASUREMENT GUIDE - 7451045, CROSS CONNECTOR HOLDER - 7451046, CROSS CONNECTOR TORQUE T-HANDLE - 7451047, CROSS CONNECTOR DRIVER - 7451048, FIXED CROSS CONNECTOR BENDER, LEFT - 7451049, FIXED CROSS CONNECTOR BENDER, RIGHT - 7451050, ROD TEMPLATE, 5.5MM X 500MM - 7451051, ROD TEMPLATE, 6.25MM X 500MM - 7451052, BALL TIP PEDICLE PROBE, WIDE - 7451053, ROD TO ROD ELEVATOR 6.25MM - 7451054, PEDICLE ELEVATOR - 7451055, HOOK INSERTER, 6.25MM ROD - 7451056, LAMINA ELEVATOR - 7451057, HOOK PUSHER - 7451058, TRANSVERSE PROCESS ELEVATOR - 7451059, PEDICLE MARKER SPHERICAL - 7451060, PEDICLE MARKER DIAMOND - 7451061, SCREW HEAD ADJUSTER 6.25MM ROD - 7451063, PLATE STYLE BENDER RIGHT - 7451065, ADJUSTABLE CROSS CONNECTOR DRIVER - 7451067, ROD HOLDER, 6.25MM ROD - 7451069, IN-SITU SAGITTAL BENDER, 6.25MM ROD, L - 7451070, IN-SITU SAGITTAL BENDER, 6.25MM ROD, R - 7451071, IN SITU CORONAL BENDERS, 6.25MM - 7451072, IN-SITU CORONAL BENDER, 6.25MM ROD, R - 7451073, DEFORMITY TULIP DEROTATION TOOL - 7451075, TULIP TO ROD ELEVATOR 5.5MM - 7451077, KERRISON PERSUADER, 5.5MM ROD - 7451078, ROCKER, 5.5MM ROD - 7451079, POLYAXIAL SCREWDRIVER, 5.5MM ROD - 7451080, SELF RETAINING SCREWDRIVER 5.5MM - 7451081, COUNTER-TORQUE, 5.5MM ROD - 7451083, LOCKSCREW/ DEROTATION GUIDE 5.5MM ROD - 7451084, LOCKSCREW STARTER 5.5MM - 7451085, LOCKSCREW STARTER STRAIGHT 5.5MM - 7451086, LOCK SCREW DRIVER, 5.5MM ROD - 7451087, FIXED SCREWDRIVER, 5.5MM ROD - 7451088, FIXED SCREWDRIVER, 6.25MM ROD - 7451089, ILIAC PROBE - 7451090, REDUCTION TOWER COUNTER TORQUE - 7451091, REDUCER, 5.5MM ROD - 7451092, REDUCER, 6.25MM ROD - 7451093, SCREW HEAD ADJUSTER, 5.5MM ROD - 7451094, IMPLANT HOLDER, 5.5MM ROD - 7451095, UNIAXIAL SCREWDRIVER, 5.5MM ROD - 7451096, UNIAXIAL SCREWDRIVER, 6.25MM ROD - 7451097, FIXED CONNECTOR BENDER, 6.25MM ROD, L - 7451098, FIXED CONNECTOR BENDER, 6.25MM ROD, R - 7451099, HOOK INSERTER, 5.5MM ROD - 7451100, ROD GRIPPER, DUAL ACTION, 6.25MM ROD - 7451101, ROD GRIPPER, DUAL ACTION, 5.5MM ROD - 7451102, REDUCER T-HANDLE - 7451103, DEFORMITY REDUCTION SCREWDRIVER - 7451104, SCREWDRIVER, ILIAC-CLOSED - 7451107, REDUCER - 7451108, REDUCER T-HANDLE - 7451109, FIXED CROSS CONNECTOR BENDER, L - 7451110, FIXED CROSS CONNECTOR BENDER, R - 7451111, SINGLE LEAD TAP, 4.0MM - 7452040, SINGLE LEAD TAP, 4.5MM - 7452045, SINGLE LEAD TAP, 5.0MM - 7452050, SINGLE LEAD TAP, 5.5MM - 7452055, SINGLE LEAD TAP, 6.5MM - 7452065, SINGLE LEAD TAP, 7.5MM - 7452075, SINGLE LEAD TAP, 8.5MM - 7452085, DOUBLE LEAD TAP, 4.0MM - 7453040, DOUBLE LEAD TAP, 4.5MM - 7453045, DOUBLE LEAD TAP, 5.0MM - 7453050, DOUBLE LEAD TAP, 5.5MM - 7453055, DOUBLE LEAD TAP, 6.5MM - 7453065, DOUBLE LEAD TAP, 7.5MM - 7453075, DOUBLE LEAD TAP, 8.5MM - 7453085, NARROW GEARSHIFT PROBE STRAIGHT - 7459003, NARROW GEARSHIFT PROBE CURVED - 7459004, DOUBLE LEAD TAP, 10.5MM TAP - 7459005, GEARSHIFT PROBE CURVED - 7459006, BALL-TIP PEDICLE PROBE - 7459007, BALL-TIP PEDICLE PROBE, DUAL - 7459008, ROCKER, LONG - 7459010, REDUCTION TOWER T-HANDLE - 7459012, REDUCTION SCREW BREAKOFF TOOL - 7459013, ARMADA SCREWDRIVER - 7459014, SELF RETAINING SCREWDRIVER - 7459015, SCREW ADJUSTER - 7459016, DEFORMITY COUNTER TORQUE - 7459017, DEFORMITY ROD PUSHER 5.5MM - 7459019, LOCK SCREW GUIDE/DEROTATION TOWER - 7459020, LOCK SCREW STARTER - 7459021, LOCK SCREW STARTER, STRAIGHT - 7459022, LOCK SCREW DRIVER 6.25MM/PLS - 7459023, ROD HOLDER - 7459024, IN SITU SAGITTAL BENDER 5.5MM ROD, L - 7459029, IN SITU SAGITTAL BENDER 5.5MM ROD, R - 7459030, IN SITU CORONAL BENDER 5.5MM ROD, LEFT - 7459031, IN SITU CORONAL BENDER 5.5MM ROD, RIGHT - 7459032, ROD ROTATION WRENCH - 7459033, DEFORMITY FRENCH BENDER - 7459036, ROD BENDER LEFT - 7459037, TABLE TOP ROD CUTTER - 7459039, IMPLANT HOLDER - 7459040, PARALLEL COMPRESSOR - 7459041, PARALLEL DISTRACTOR - 7459043, CROSS CONNECTOR MEASUREMENT GUIDE - 7459045, CROSS CONNECT HOLDER, FIXED - 7459046, DEFORMITY PEDICLE ELEVATOR - 7459055, DEFORMITY HOOK INSERTER 6.25MM - 7459056, DEFORMITY LAMINA ELEVATOR - 7459057, DEFORMITY HOOK PUSHER - 7459058, DEFORMITY TRANSVERSE PROCESS ELEVAT

승인 날짜:

2011-06-22