CONSIDERANDO QUE ANTE ESTE INSTITUTO SE HA SOLICITADO LA CONCESIÓN DE UN REGISTRO SANITARIO AUTOMATICO CON BASE EN LA VERIFICACIÓN DE LA DOCUMENTACIÓNTÉCNICO LEGALALLEGADAANTE LA DIRECCIÓN DE DISPOSITIVOS MÉDICOS Y OTRAS TECNOLOGÍAS,EMITIENDOCONCEPTOFAVORABLEPARALA EXPEDICIÓNDE ESTE REGISTROSANITARIO. EN CONSECUENCIAA LO ANTERIOR,DE CONFORMIDADCON EL ARTICULO57 DE LA LEY 962 DE 2005 EL INVIMA REALIZARAEL CONTROLPOSTERIORDENTRODE LOS QUINCE (15) DIAS SIGUIENTESA SU EXPEDICIÓN. RESUELVE ARTICULO PRIMERO.-CONCEDERREGISTROSANITARIO POR EL TÉRMINO DE DIEZ (10) AÑOS A PRODUCTO: SISTEMA INSTRUMENTAL PARA USO EN PROCEDIMIENTOS DE CIRUGIA GUIADA POR IMAGEN- MEDTRONIC INCLUYE SOFTWARE Y ACCESORIOS. - STEALTHSTATION - MEDTRONIC REGISTROSANITARIO NO.: INVIMA2013DM-0010390 VIGENTEHASTA: TIPO DE REGISTRO: IMPORTARY VENDER TITULAR(ES): MEDTRONICINC. CON DOMICILIO EN ESTADOSUNIDOS DE AMÉRICA FABRICANTE(S): MEDTRONICNAVIGATIONINC. CON DOMICILIO EN ESTADOSUNIDOS DE AMÉRICA NORTHENDIGITALINC CON DOMICILIO EN CANADA IMPORTADOR(ES): MEDTRONICLATIN AMERICAINC. CON DOMICILIO EN BOGOTA- D.C. MEDIREXS.A.S CON DOMICILIO EN BOGOTA- D.C. TIPO DE DISPOSITIVO INVASIVO RIESGO: IIA COMPOSICIÓN: EL SISTEMASE COMPONEDE INSTRUMENTOSQUIRÚRGICOS,ACCESORIOSY SOFTWAREDE APLICACIÓN. LOS INSTRUMENTOS SON FABRICADOS EN ACERO INOXIDABLE GRADO QUIRÚRGICO, CON EXCEPCIÓN DE SUS MANIJAS QUE ESTÁN HECHAS DE ACRILONITRILO BUTADIENOESTIRENO(ABS);ALEACIÓNDE TITANIO,ALUMINIO,SILICONA. USOS: TANTO EL SOFTWARE COMO EL INSTRUMENTAL Y LOS ACCESORIOS SON PARA USO EXCLUSIVO CON EL SISTEMA DE CIRUGÍA ASISTIDA POR ORDENADOR DE MEDTRONIC EL CUAL ESTA INDICADO PARA USO EN PROCEDIMIENTOSDE NEUROCIRUGIA,DE LA COLUMNA VERTEBRAL, ORTOPÉDICOS (CADERA, RODILLA) Y CIRUGÍA DE ENT (OÍDO, NARIZ Y GARGANTA).EL SISTEMAPERMITE LA UBICACIÓNEXACTADE ESTRUCTURASANATÓMICASY PLANIFICAR TRAYECTORIAS QUIRÚRGICAS EN INTERVENCIONES ABIERTAS Y PERCUTÁNEAS. PRESENTACIÓNCOMERCIAL: EMPAQUEUNITARIO OBSERVACIONES: EL PRESENTEREGISTROSANITARIO AMPARALAS SIGUIENTESREFERENCIAS: CODIGO CRANIAL SOFTWARE DESCRIPCION 9733937 SYNERGY CRANIALSOFTWAREPLANNING& NAVIGATIONMODULE 9734011 STEALTHMERGE FOR SYNERGY CRANIAL 9734046 STEALTH3DFOR SYNERGY CRANIAL 9734047 FRAMELINK STEREOTACTICPLANNINGSOFTWAREFOR STEALTHSTATION S7 NAVIGATIONSYSTEM 9733265 PASSIVE BIOPSY NAVIGUSSET 9733157 NAVIGUSPROBE 9733936 PASSIVE BIOPSY VERTEK SET 960-535 DOUBLESTAR ADAPTER- MAYFIELDMOUNT 9734252 VERTEK II ARTICULATINGARM 960-539 BIOPSYGUIDE 9733214 2.2MM REDUCINGTUBE 9733158 VERTEK PROBE 961-574 SURETRAK II UNIVERSALTRACKER,PASSIVE SYSTEM 9731567 SURETRAK II UNIVERSALTRACKER,SMALLPASSIVE FIGHTER 961-576 SURETRAK II UNIVERSALTRACKER,SMALLCLAMP Página 1 de 9
961-578 SURETRAK II UNIVERSALTRACKER,MEDIUM CLAMP 961-579 SURETRAK II UNIVERSALTRACKER,MEDIUM PASSIVE FIGHTER 961-580 SURETRAK II UNIVERSALTRACKER,LARGECLAMP 961-581 SURETRAK II UNIVERSALTRACKER,LARGEPASSIVE FIGHTER 961-583 SURETRAK II UNIVERSALTRACKERINSTRUMENTTRAY 961-584 SURETRAK II UNIVERSALTRACKER,CLAMPDRIVER 9732582 9731450 9734252 9731833 9732566 9730889 AXIEM CRANIAL APPLICATION KIT MOBILEEMITTER HOLDER VERTEK II ARTICULATINGARM 1/4"BALLHEX DRIVER SHORT BED RAIL ADAPTER AXIEM CRANIALSOFTWARE(MACH)PLANNING& NAVIGATIONMODULES CRANIAL NAVIGATIONPROBES 9730092 PASSIVE CATHETERINTRODUCER(PCI) HANDLE 9732176 TOUCH-N-GO PROBE 9730269 M ICROSCOPEPROBE 9733423 TRACER POINTERS,5-PK 9733424 TOUCH-N-GO POINTERS,5-PK 9733935 961-337 9734252 960-195 9733771 CRANIAL PASSIVE INSTRUMENTSET PASSIVE PLANARBLUNTPROBE SMALLPASSIVE CRANIALREFERENCEFRAME VERTEK II ARTICULATINGARM SKULLMODEL CRANIALPASSIVE INSTRUMENTTRAY CRANIAL DISPOSABLES 960-991 FIDUCIALMARKERS100 PACK (ORDER THROUGHIZI) 9733068 PASSIVE BIOPSYNEEDLE 9733065 EXTERNAL,BIOPSYTRAJECTORYGUIDE KIT (NAVIGUS) 9733066 INTERNAL,BIOPSYTRAJECTORYGUIDE KIT (NAVIGUS) 9731115 PCI TIPS 9733607 AXIEM CRANIALNON-INVASIVE TUMOR RESECTIONKIT 9733605 AXIEM CRANIALNON-INVASIVE SHUNT KIT 9733606 AXIEM CRANIALSKULLMOUNTEDSHUNT KIT 9733608 AXIEM CRANIALSKULLMOUNTEDTUMORRESECTIONKIT 9732571 AXIEM EMITTER DRAPE 9660245 AXIEM EMITTER CABLECLIP 9735030 9734999 9734990 STEALTHAIR ICT CRANIAL KIT RADIOLUCENTARTICULATINGARM STEALTHAIR RADIOLUCENTCRANIALREFERENCEFRAME Página 2 de 9
SPINE SOFTWARE 9733990 9734833 9734590 9734683 9734682 9734734 9734914 9733734 9734678 9734679 9734680 9734631 9734240 9734239 9734238 9734274 9734275 9734374 9734278 9734632 9734302 9734300 9734298 9734856 9734492 9734303 9734301 9734299 9734297 9734296 9734304 9734031 9734493 9734282 9734283 9734284 9734285 SYNERGY SPINE SOFTWAREFOR STEALTHSTATION S7 NAVIGATIONSYSTEM STEALTHSTATION NAVLOCK INSTRUMENTSET NAVLOCK TRACKERGREY NAVLOCK TRACKERORANGE NAVLOCK TRACKERVIOLET NAVLOCK TRACKERGREEN KIT NAVLOCK TRACKERGREEN RATCHETINGSMALLSTRAIGHTHANDLEX2 NAV SHARP AWL TIP NAV LUMBARPROBETIP NAV THORACIC PROBETIP STEALTHSTATION C D HORIZON LEGACY TAPS & DR IVERS NAV 6.5MM TAP (CANNULATED) NAV 5.5MM TAP (CANNULATED) NAV 4.5MM TAP (CANNULATED) NAV CD HORIZON LEGACY5.5MM DRIVER NAV CD HORIZON REDUCTIONDRIVER NAV CD HORIZON LEGACY PEEK REDUCTIONDRIVER NAV CD HORIZON LEGACY PEEK DRIVER STEALTHSTATION C D HORIZON SOLERA TAPS & DR IVERS 6.5MM TAP (CANNULATED) 5.5MM TAP (CANNULATED) 4.5MM TAP (CANNULATED) NAV CD HORIZON SOLERA MAST 4.75 DRIVER SOLERAOPTIONALDE FORMITY UPGRADE 7.5MM TAP (CANNULATED) 6.0MM TAP (CANNULATED) 5.0MM TAP (CANNULATED) 4.0MM TAP (NON-CANNULATED) 3.75MM TAP (NON-CANNULATED) 8.5MM TAP NAV CD HORIZON SOLERA MAST REDUCTION4.75 DRIVER STEALTHSTATION C D HORIZON LEGACYAWL TIP TAPS 4.0-4.5MM AWL TIP TAP 4.5-5.5MM AWL TIP TAP 5.5-6.5MM AWL TIP TAP 6.5-7.5MM AWL TIP TAP Página 3 de 9
9734028 4.0-4.5MM DIALATOR,CHAMFER 9734029 4.5-5.5MM DIALATOR,CHAMFER 9734030 5.5-6.5MM DIALATOR,CHAMFER 9734031 6.5-7.5 MM DIALATOR,CHAMFER 9734836 9734456 9734592 9731958 9734834 9734555 9734559 9734563 9734567 9731958 9734835 9734653 9734654 9734655 9734656 9734657 9734658 9734659 9734660 9734661 9734662 9734663 9734664 9731958 9734495 9731780 9730027 9733148 9730605 960-559 9734501 9732562 9732564 9732353 9732563 TLIF/DLIF INSERTER,CAPSTONE& CLYDESDALE SET CAPSTONE& CLYDESDALE SLAM HAMMER TOLLSUPGRADECD CAPSTONETRIALS SET (TLIF/PLIF) 8 X 26 MM CAPSTONETRIAL 10 X 26 MM CAPSTONETRIAL 12 X 26 MM CAPSTONETRIAL 14 X 26 MM CAPSTONETRIAL TOOLSUPGRADECD CLYDESDALE TRIAL SET (DLIF) 8 X 45 MM CLYDESDALETRIAL 8 X 50 MM CLYDESDALETRIAL 8 X 55 MM CLYDESDALETRIAL 10 X 45 MM CLYDESDALETRIAL 10 X 50 MM CLYDESDALETRIAL 10 X 55 MM CLYDESDALETRIAL 12 X 45 MM CLYDESDALETRIAL 12 X 50 MM CLYDESDALETRIAL 12 X 55 MM CLYDESDALETRIAL 14 X 45 MM CLYDESDALETRIAL 14 X 50 MM CLYDESDALETRIAL 14 X 55 MM CLYDESDALETRIAL TOOLSUPGRADECD STEALTHSTATION SPINE REFERENCINGSET OPEN SPINE CLAMP OPEN SPINE CLAMP,RADIOLUCENTDRIVER THORACIC CLAMP,RADIOLUCENT REFERENCEFRAME,SMALLPASSIVE PASSIVE PLANARBALL-TIPPED PROBE OPTIONALPERC PIN UPGRADE CROSS PIN TAP CAP CROSS PIN SLAP HAMMER PERCUTANEOUSREFERENCECROSS PIN FRAME CANNULA100MM Página 4 de 9
9732565 DILATOR100MM 9732772 CANNULA150MM 9732771 DILATOR150MM 9734502 9733817 9733816 963-791 963-792 963-794 9734439 963-793 963-795 9734507 9730432 9734036 960-521 960-522 960-523 960-524 960-527 960-717 9734450 9734494 9734450 9734433 9734434 9734436 9734437 9730490 9730491 9730489 9733457 9734435 9733370 9732355 9733332 9733140 9733139 9733649 9733457 OPTIONALMAST UPGRADE NAVIGATEDDILATOR DILATORTRACKER LONG PERCUTANEOUSCLAMP SHORT PERCUTANEOUSCLAMP 45 PERCUTANEOUSSTARBURST PERCUTANEOUSCLAMPDRIVER PERCUTANEOUSSTARBURST PERCUTANEOUSCLAMPDRIVER STEALTHSTATION UNIVERSALDR ILL GUIDE SET TERETRACKER,PURPLE AGGRESSIVETIP DRILL GUIDE BIT UNIVERSALDRILLGUIDE TROCAR- UNIVERSALDRILL GUIDE BIT GUIDE 3MM - UNIVERSALDRILLGUIDE BIT 3MM - UNIVERSALDRILL GUIDE CANCELLOUSBIT 3MM - UNIVERSALDRILLGUIDE ADJ. DRILLSTOP 3.2MM FIGHTER INSERTION / REMOVALTOOL STEALTHSTATION TACTILE PROBE SET FIGHTER INSERTION / REMOVALTOOL PROBE,RIGHT LUMBARTACTILE PROBE,LEFT LUMBARTACTILE PROBE,LEFT THORACIC TACTILE PROBE,RIGHT THORACIC TACTILE TERETRACKER,GREEN TERETRACKER,GOLD TERETRACKER,BLUE PROBEPEDICLE2.25MM TACTILE AWL STEALTHSTATION VERTEXMAX SET VERTEXMAX CANNULATEDDRILL GUIDE ADJUSTABLESTOP BIT GUIDE TROCAR COUNTERTORQUEASSEMBLYDRIVER 2.25MM PEDICLEPROBE Página 5 de 9
9733037 AXIEM SPINE REFERENCECLAMP 9733504 0 LIGHT REFERENCE 9733505 90 LIGHT REFERENCE 9733223 CANNULATEDUNIVERSALHANDLE 960-553 PASSIVE PLANARSHARP PROBE 9733509 3.5MM TAP 9733510 4.0 TAP (10-24) 9733511 4.0MM TAP (26-52) 9733512 4.5 TAP 9733513 4.0MM TAP, CORTICAL 9733514 4.5 TAP, CORTICAL 9733161 AWL 9733182 4.0MM CANNULATEDTAP, 1.86P 9733183 4.5MM CANNULATEDTAP 9733184 4.0MM CANNULATEDTAP, 1.5P, UCSS 9734901 9734833 9734495 9734631 9734507 9734902 9734833 9734495 9734632 9734507 STEALTHSTATION NAVLOCK LEGACYBASIC SPINE SET STEALTHSTATION NAVLOCK INSTRUMENTSET STEALTHSTATION SPINE REFERENCINGSET STEALTHSTATION CD HORIZON LEGACY TAPS & DRIVERS STEALTHSTATION UNIVERSALDRILL GUIDE SET STEALTHSTATION NAVLOCK SOLERABASIC SPINE SET STEALTHSTATION NAVLOCK INSTRUMENTSET STEALTHSTATION SPINE REFERENCINGSET STEALTHSTATION CD HORIZON SOLERA TAPS & DRIVERS STEALTHSTATION UNIVERSALDRILL GUIDE SET SPINE DISPOSABLES 9733235 100 MM DISPOSABLEPIN 9733236 150 MM DISPOSABLEPIN 9733992 STARTERKIT - DRILL BITS 9733515 2.4 MM DRILL BIT 9733516 2.9 MM DRILL BIT 9733517 3.0 MM DRILL BIT 9733518 3.5 MM DRILL BIT 9733519 3.0 MM CANNULATEDDRILL BIT PEDACLE ACCESSKIT (PAK) 9733498 PAK NEEDLEKIT 9733497 NAVIGATEDNIM-SPINE SYSTEM PAK NEEDLE OTHER INSTRUMENTS 9733530 1.5 MM AWL TIP Página 6 de 9
9733531 2.0 MM PROBETIP 9732296 2.5 BALLLONG POINTER PROBE 962-123 JAMSHIDIMOUNT 7486111 6.35 MAS CD HORIZON LEGACY IMAGE GUIDED SCREWD 7480111 5.5 MAS LEGACY IMAGE GUIDED SCREWDRIVER ORTHO SO FTWARE 9734377 9734376 9732622 9732269 9732159 9732160 9732520 9732236 9730873 9732630 9732623 9733887 9730864 9732269 9732236 9730873 9732630 DISPOSABLES 9733088 9733089 9732540 9730864 9730873 963-850 9730288 9730422 9730478 9730492 9730490 9730289 IMAGELESSKNEE APPLICATION(COMPATIBLEW ITH STEALTHSTATION S7 ) IMAGELESSHIP APPLICATION(COMPATIBLEW ITH STEALTHSTATION S7 ) ITKR - WIRELESSINSTRUMENTKIT VERIFICATIONPLATE QU ICK RELEASEFRAME1 QU ICK RELEASEFRAME2 QU ICK RELEASEBASE X 2 PLANARPASSIVE BLUNT PASSIVE SPRING PADDLE W RENCHHEX 4.0MM KNEE STERILIZATION TRAY ITKR - WIRED INSTRUMENTKIT ORTHOPAEDICFRAME HC 2 PIN FIXATOR VERIFICATIONPLATE PLANARPASSIVE BLUNTPROBE PASSIVE SPRING PADDLE HEX W RENCH4.0 MM KNEE STERILIZATION TRAY 125 MM STERILEPIN PACK 75 MM STERILEPIN PACK HIP INSTRUMENTSET FOR ITHR 2 PIN FIXATOR W RENCHHEX, 4MM PLANARPASSIVE BLUNTPROBE FIGHTER INSERTION/REMOVALTOOL ADAPTER,REAMERPRECIMED SLEEVETEFLONREAMERPRECIMED VERIFICATIONTIP PURPLETERATRACKER GREEN TERATRACKER CLAMP,ORTHO-DOVETAIL Página 7 de 9
9732520 QU ICK RELEASEBASESX2 9732159 QU ICK RELEASEFRAME1 9732160 QU ICK RELEASEFRAME2 9732664 ITHR INSTRUMENTTRAY 9732164 963-774 963-775 963-776 963-777 963-778 963-864 9733887 9730864 9730711 9730873 963-850 9732220 9730489 9733362 9732353 9732562 9732563 9732564 9732565 9732771 9732772 DISPOSABLES 9733235 9733236 ORTHO TRAUMAINSTRUMENTS MODULARDRILL GUIDE-SHORT CANNULA,2.5 MM DIAMETER CANNULA,2.9 MM DIAMETER CANNULA,3.2 MM DIAMETER CANNULA,4.5 MM DIAMETER ORTHOPAEDICFRAME,PASSIVE ORTHOPAEDICFRAME,HC 2-PIN FIXATOR PROD DESC ORTHO REF FRAMES W RENCHHEX, 4.0 MM FIGHTER INSERTION/REMOVALTOOL PLANARPASSIVE BLUNTPROBE ORTHO DRILL GUIDE INSTRUMENTTRAY TERA TRACKERBLUE PERCUTANEOUSREFERENCEPIN SET PERCUTANEOUSREFERENCECROSS PIN FRAME CROSS PIN TAP CAP 100 MM CANNULA CROSS PIN SLAP HAMMER 100 MM DILATOR 150 MM DILATOR 150 MM CANNULA 100 MM DISPOSABLEPIN 150 MM DISPOSABLEPIN STEALTHSTATION PASSIVE SPHERE 8801071 8801074 8801075 1-PACK/12 PACKSPER BOX (12 PCS) 4-PACK/12 PACKSPER BOX (48 PCS) 5-PACK/12 PACKSPER BOX (60 PCS) EXPEDIENTENO.: 20066439 RADICACIÓNNO.: 2013099954 FECHADE RADICACION: 04 09 2013 ARTICULO SEGUNDO.- CONTRA LA PRESENTE RESOLUCIÓN PROCEDE ÚNICAMENTE EL RECURSO DE REPOSICIÓN, QUE DEBERÁ INTERPONERSE ANTE EL DIRECTOR DE DISPOSITIVOS MÉDICOS Y OTRAS TECNOLOGÍAS,DENTRO DE LOS DIEZ (10) DÍAS SIGUIENTES A SU NOTIFICACIÓN,EN LOS TÉRMINOS SEÑALADOSEN EL CÓDIGO DE PROCEDIMIENTO ADMINISTRATIVO Y DE LO CONTENCIOSOADMINISTRATIVO. ARTICULO TERCERO.-LA PRESENTERESOLUCIÓNRIGE A PARTIR DE LA FECHADE SU EJECUTORIA. Página 8 de 9
ARTICULO CUARTO.- LOS DERECHOSQUE SE DERIVEN DE ESTA RESOLUCIÓN QUEDARAN SUJETAS AL CONTROLPOSTERIOR QUE DEBE REALIZAR EL INSTITUTO NACIONALDE VIGILANCIADE MEDICAMENTOSY ALIMENTOSINVIMA DE CONFORMIDADCON LO PREVISTO POR EL ARTICULO22 DEL DECRETO4725 DE 2005. DADAEN BOGOTÁD.C. A LOS 5 DE SEPTIEMBREDE 2013 ESTE ESPACIO,HASTA LA FIRMA SE CONSIDERAEN BLANCO. VoBo Técnico: VoBo Legal: Aprobó: COMUNIQUESE,NOTIFIQUESE Y CUMPLASE ELKIN HERNÁN OTALVARO CIFUENTES DIRECTOR DE DISPOSITIVOS MEDICOS Y OTRAS TECNOLOGÍAS Página 9 de 9