NuVasive SpheRx II Spinal System

Nazione: Singapore

Lingua: inglese

Fonte: HSA (Health Sciences Authority)

Commercializzato da:

NUVASIVE SOUTHEAST ASIA PTE. LTD.

Classe:

Class C medical device

Prodotto da:

Nuvasive Inc

Area terapeutica:

Orthopaedics

Indicazioni terapeutiche:

When used as a pedicle screw fixation system, it 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: Degenerative disc disease, Degenerative spondylolisthesis with objective evidence of neurologic impairment, Fracture, Dislocation, Scoliosis, Kyphosis, Spinal tumor and/or 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. When used as an anterolateral non-pedicle screw system in the thoracic and lumbar spine, it is also intended for: Degenerative disc disease, Spinal stenosis,

Dettagli prodotto:

Device System Info:[System or Procedure Pack], It consisted of the implants and instruments.; Models: Cervical Mallet - 1006278, Ball-tip Probe - 7200028, Ball-Tip Pedicle Probe, Curved - 7200029, Rod Cutter - 7200048, Cannulated Driver, 8" - 1008935, T-Handle w/ AO Quick Connect - 1002007, TLIF Distractor, Size 10-19mm - 7100125, TLIF Distractor, Size 10-24mm - 7100126, TLIF Distractor, Size 10-29mm - 7100127, TLIF Distractor, Size 10-34mm - 7100128, TLIF Distractor, Size 10-39mm - 7100129, TLIF Distractor Removal Tool - 7100132, Measurement Tool, TLIF Distractor - 7100133, TLIF Distractor Inserter - 7100134, 3.5mm Tapered Hex Driver - 7100135, Detachable Driver-Quick Connect - 7100136, 5.5mm x 35mm Detachable Tap - 7101535, 5.5mm x 40mm Detachable Tap - 7101540, 5.5mm x 45mm Detachable Tap - 7101545, 6.5mm x 35mm Detachable Tap - 7101635, 6.5mm x 40mm Detachable Tap - 7101640, 6.5mm x 45mm Detachable Tap - 7101645, 4.5mm x 35mm Self-Tapping Screw - 7104535, 4.5mm x 40mm Self-Tapping Screw - 7104540, 4.5mm x 45mm Self-Tapping Screw - 7104545, Primary Insulator - 7210031, DBR® Tap Insulator - 7230141, Curved Gearshift Probe - 7240012, SpheRx® II MAS Screwdriver - 7247001, SpheRx® II MAS Compressor - 7247002, SpheRx® II MAS Distractor - 7247003, SpheRx® II MAS Rod Holder - 7247004, SpheRx® II MAS Persuader - 7247005, SpheRx® II MAS Counter Torque - 7247006, Quick-Connect Straight Handle, Short - 7270049, Blunt Tip K-Wire - 7270100, Quick Connect Straight Handle - 7240010, Straight Gearshift Probe - 7240011, Tap Insulator - 7240027, Screw Insulator - 7240028, Pedicle Marker, Spherical - 7240029, Pedicle Marker, Diamond - 7240030, Self-Retaining Screwdriver - 7240037, Polyaxial Screwdriver - 7240038, Screw Adjuster - 7240039, Quick Connect T-Handle - 7240041, Awl - 7240042, Narrow Awl - 7240043, NARROW GEARSHIFT PROBE, STRAIGHT - 7240047, Narrow Gearshift Probe, Curved - 7240059, Screw Head Adjuster - 7240050, 4.5mm Tap - 7240145, 5.5mm Tap - 7240155, 6.5mm Tap - 7240165, 7.5mm Tap - 7240175, 8.5mm Tap - 7240185, LOCK SCREW STARTER - 7240013, Rocker - 7240014, Cross Connector Holder - 7240015, Cross Connector Screwdriver - 7240016, Compressor - 7240019, Distractor/TC Lock Ring Driver - 7240020, Rod Gripper - 7240022, Rod Pusher - 7240023, Counter Torque - 7240024, Torque T-Handle - 7240025, Cross Connector Measurement Guide - 7240026, Implant Holder - 7240031, Rod Template, 250mm - 7240033, Rod Template, 500mm - 7240034, In-Situ Bender, Right - 7240036, In-Situ Bender, Left - 7240075, Lock Screw Driver - 7240040, Cross Connector Bender, Left - 7240044, Cross Connector Bender, Right - 7240045, Grip Reducer - 7240048, Lock Screw Starter Guide - 7240051, Straight Rod Holder - 7240062, Lock Screw Starter, Straight - 7240063, SpheRx® II Rod Bender - 7240074, Transverse Connector Driver - 7240079, SPII Transverse Connector Torque T-Handl - 7240084, Hook Pusher - 7240052, Lamina Elevator - 7240053, Transverse Process Elevator - 7240054, Hook Inserter - 7240055, Fixed Head Screwdriver - 7240056, Pedicle Elevator - 7240060, SPHERX II REDUCTION SCREWDRIVER - 7240085, REDUCTION COUNTER TORQUE - 7240086, REDUCTION SCREW BREAKOFF TOOL - 7240087, SPHERX II DOUBLE LEAD TAP 1533796 - 7190055, SPHERX II DOUBLE LEAD TAP 1533797 - 7190065, SPHERX II DOUBLE LEAD TAP 1533798 - 7190075, 5.5mm X 35mm Double Lead Screw - 7195535, 5.5mm X 40mm Double Lead Screw - 7195540, 5.5mm X 45mm Double Lead Screw - 7195545, 5.5mm X 50mm Double Lead Screw - 7195550, 5.5mm X 55mm Double Lead Screw - 7195555, 6.5mm X 35mm Double Lead Screw - 7196535, 6.5mm X 40mm Double Lead Screw - 7196540, 6.5mm X 45mm Double Lead Screw - 7196545, 6.5mm X 50mm Double Lead Screw - 7196550, 6.5mm X 55mm Double Lead Screw - 7196555, 7.5mm X 35mm Double Lead Screw - 7197535, 7.5mm X 40mm Double Lead Screw - 7197540, 7.5mm X 45mm Double Lead Screw - 7197545, 7.5mm X 50mm Double Lead Screw - 7197550, 7.5mm X 55mm Double Lead Screw - 7197555, ADJUSTABLE TRANSVERSE CONNECTOR, 40-49mm - 7241040, ADJUSTABLE TRANSVERSE CONNECTOR, 45-60mm - 7241045, ADJUSTABLE TRANSVERSE CONNECTOR, 55-77mm - 7241055, Adjustable Transvere Connector 75-100mm - 7241075, SpheRx® II Lock Screw - 7241100, Fixed Transverse Connector, 20mm - 7241200, Fixed Transverse Connector, 22.5mm - 7241225, FIXED TRANSVERSE CONNECTOR, 25mm - 7241250, Fixed Transverse Connector, 27.5mm - 7241275, FIXED TRANSVERSE CONNECTOR, 30mm - 7241300, Fixed Transverse Connector, 32.5mm - 7241325, FIXED TRANSVERSE CONNECTOR, 35mm - 7241350, Fixed Transverse Connector, 37.5mm - 7241375, FIXED TRANSVERSE CONNECTOR, 40mm - 7241400, FIXED TRANSVERSE CONNECTOR, 45mm - 7241450, FIXED TRANSVERSE CONNECTOR, 50mm - 7241500, Fixed Transverse Connector, 55mm - 7241550, Fixed Transverse Connector, 60mm - 7241600, Arch, Adjust. Trans Connector, 45-50mm - 7243045, Arch, Adjust. Trans Connector, 50-60mm - 7243050, Arch, Adjust. Trans Connector, 60-70mm - 7243060, Arch, Adjust. Trans Connector, 70-85mm - 7243070, 5.5mm X 30mm POLYAXIAL SCREW 5.5mm ROD - 7245530, 5.5mm X 35mm POLYAXIAL SCREW 5.5mm ROD - 7245535, 5.5mm X 40mm POLYAXIAL SCREW 5.5mm ROD - 7245540, 5.5mm X 45mm POLYAXIAL SCREW 5.5mm ROD - 7245545, 5.5mm X 50mm POLYAXIAL SCREW 5.5mm ROD - 7245550, 5.5mm X 55mm POLYAXIAL SCREW 5.5mm ROD - 7245555, 5.5mm X 60mm POLYAXIAL SCREW 5.5mm ROD - 7245560, 6.5mm X 30mm POLYAXIAL SCREW 5.5mm ROD - 7246530, 6.5mm X 35mm POLYAXIAL SCREW 5.5mm ROD - 7246535, 6.5mm X 40mm POLYAXIAL SCREW 5.5mm ROD - 7246540, 6.5mm X 45mm POLYAXIAL SCREW 5.5mm ROD - 7246545, 6.5mm X 50mm POLYAXIAL SCREW 5.5mm ROD - 7246550, 6.5mm X 55mm POLYAXIAL SCREW 5.5mm ROD - 7246555, 6.5mm X 60mm POLYAXIAL SCREW 5.5mm ROD - 7246560, 7.5mm X 30mm POLYAXIAL SCREW 5.5mm ROD - 7247530, 7.5mm X 35mm POLYAXIAL SCREW 5.5mm ROD - 7247535, 7.5mm X 40mm POLYAXIAL SCREW 5.5mm ROD - 7247540, 7.5mm X 45mm POLYAXIAL SCREW 5.5mm ROD - 7247545, 7.5mm X 50mm POLYAXIAL SCREW 5.5mm ROD - 7247550, 7.5mm X 55mm POLYAXIAL SCREW 5.5mm ROD - 7247555, 7.5mm X 60mm POLYAXIAL SCREW 5.5mm ROD - 7247560, 8.5mm X 30mm POLYAXIAL SCREW 5.5mm ROD - 7248530, 8.5mm X 35mm POLYAXIAL SCREW 5.5mm ROD - 7248535, 8.5mm X 40mm POLYAXIAL SCREW 5.5mm ROD - 7248540, 8.5mm X 45mm POLYAXIAL SCREW 5.5mm ROD - 7248545, 8.5mm X 50mm POLYAXIAL SCREW 5.5mm ROD - 7248550, 8.5mm X 55mm POLYAXIAL SCREW 5.5mm ROD - 7248555, 8.5mm X 60mm POLYAXIAL SCREW 5.5mm ROD - 7248560, 4.5mm X 25mm POLYAXIAL SCREW 5.5mm ROD - 7284525, 4.5mm X 30mm POLYAXIAL SCREW 5.5mm ROD - 7284530, 4.5mm X 35mm POLYAXIAL SCREW 5.5mm ROD - 7284535, 4.5mm X 40mm POLYAXIAL SCREW 5.5mm ROD - 7284540, 4.5mm X 45mm POLYAXIAL SCREW 5.5mm ROD - 7284545, 4.5mm X 50mm POLYAXIAL SCREW 5.5mm ROD - 7284550, 6.5mm X 65mm POLYAXIAL SCREW 5.5mm ROD - 7246565, 6.5mm X 70mm POLYAXIAL SCREW 5.5mm ROD - 7246570, 6.5mm X 75mm POLYAXIAL SCREW 5.5mm ROD - 7246575, 6.5mm X 80mm POLYAXIAL SCREW 5.5mm ROD - 7246580, 7.5mm X 65mm POLYAXIAL SCREW 5.5mm ROD - 7247565, 7.5mm X 70mm POLYAXIAL SCREW 5.5mm ROD - 7247570, 7.5mm X 75mm POLYAXIAL SCREW 5.5mm ROD - 7247575, 7.5mm X 80mm POLYAXIAL SCREW 5.5mm ROD - 7247580, 8.5mm X 65mm POLYAXIAL SCREW 5.5mm ROD - 7248565, 8.5mm X 70mm POLYAXIAL SCREW 5.5mm ROD - 7248570, 8.5mm X 75mm POLYAXIAL SCREW 5.5mm ROD - 7248575, 8.5mm X 80mm POLYAXIAL SCREW 5.5mm ROD - 7248580, 5.5mm SINGLE BALL ROD, 25mm - 7291025, 5.5mm SINGLE BALL ROD, 30mm - 7291030, 5.5mm SINGLE BALL ROD, 35mm - 7291035, 5.5mm SINGLE BALL ROD, 40mm - 7291040, 5.5mm SINGLE BALL ROD, 45mm - 7291045, 5.5mm SINGLE BALL ROD, 50mm - 7291050, 5.5mm SINGLE BALL ROD, 55mm - 7291055, 5.5mm SINGLE BALL ROD, 60mm - 7291060, 5.5mm SINGLE BALL ROD, 65mm - 7291065, 5.5mm SINGLE BALL ROD, 70mm - 7291070, 5.5mm SINGLE BALL ROD, 80mm - 7291080, 5.5mm SINGLE BALL ROD, 90mm - 7291090, 5.5mm SINGLE BALL ROD, 100mm - 7291100, 5.5mm SINGLE BALL ROD, 120mm - 7291120, 5.5mm SINGLE BALL ROD, 140mm - 7291140, 5.5mm SINGLE BALL ROD, 160mm - 7291160, 5.5mm SINGLE BALL ROD, 180mm - 7291180, 5.5mm SINGLE BALL ROD, 200mm - 7291200, 5.5mm SINGLE BALL ROD, 300mm - 7291300, 5.5mm SINGLE BALL ROD, 500mm - 7291500, 5.5mm PREBENT ROD, 25mm - 7292025, 5.5mm PREBENT ROD, 30mm - 7292030, 5.5mm PREBENT ROD, 35mm - 7292035, 5.5mm PREBENT ROD, 40mm -

Data dell'autorizzazione:

2011-06-22