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Dispositivos MédicosAtivo

INSTRUMENTAIS SPHERX II NUVASIVE

80074640003
Informações Gerais

Nome do produto

INSTRUMENTAIS SPHERX II NUVASIVE

Número de registro

80074640003

Classe de risco

I

Processo

25351726263200807

Empresa Detentora

Fabricante

NUVASIVE, INC.

País de fabricação

ESTADOS UNIDOS DA AMÉRICA

Registro

Situação

Ativo

Vencimento

Registro vigente

Registro de prazo indeterminado

Histórico de Situação
VálidoATIVO07/05/2026

Detectado a cada sincronização diária com a ANVISA.

Apresentações / Modelos(368)

  • 1006278 Cervical Mallet

  • 1006278 Cervical Mallet

  • 1007548 SPS-Riley Medium Tray With Lid

  • 1007548 SPS-Riley Medium Tray With Lid

  • 1542602 Anterior Compressor Arm

  • 1542602 Anterior Compressor Arm

  • 1542603 Anterior Compressor Arm

  • 7100125 TLIF Distractor, Size 10-19mm

  • 7100126 TLIF Distractor, Size 10-24mm

  • 7100127 TLIF Distractor, Size 10-29mm

  • 7100128 TLIF Distractor, Size 10-34mm

  • 7100129 TLIF Distractor, Size 10-39mm

  • 7100132 TLIF Distractor Removal Tool

  • 7100133 Measurement Tool, TLIF Distractor

  • 7100134 TLIF Distractor Inserter

  • 7100135 3.5mm Tapered Hex Driver

  • 7100136 Detachable Driver-Quick Connect

  • 7101535 5.5mm x 35mm Detachable Tap

  • 7101545 5.5mm x 45mm Detachable Tap

  • 7101635 6.5mm x 35mm Detachable Tap

  • 7101645 6.5mm x 45mm Detachable Tap

  • 7190001 SpheRx® II Double Lead Screw Tray, Base

  • 7190003 SpheRx® II Double Lead Screw Tray, Lid

  • 7190055 SpheRx® II Double Lead TaP 1533796

  • 7190065 SpheRx® II Double Lead Tap 1533797

  • 7190075 SpheRx® II Double Lead Tap 1533798

  • 7200005 SpheRx® II Hook/Fixed Screw Tray, Base

  • 7200006 Sterilization Case SpheRx® 4.5mm Screws

  • 7200008 Sterilization Case SpheRx® Tray 1

  • 7200009 Sterilization Case SpheRx® Tray 2

  • 7200010 Implant Tray 3

  • 7200023 Awl

  • 7200026 Driver Handle, Straight

  • 7200027 T-handle

  • 7200028:Procurador de Pedículo, Curvo

  • 7200029:Procurador de Pedículo, Reto

  • 7200030 Depth Gauge

  • 7200031 DBR® Rod Holder

  • 7200032 Rod Holder, Straight

  • 7200033 Rod Holder, Angled

  • 7200034 Rod Gripper

  • 7200035:Dobrador de Haste

  • 7200036 Rod Pusher

  • 7200037 Rod Fork

  • 7200039 Lock Screw Driver

  • 7200040 Anti Torque Tool

  • 7200041 Torque T-Handle

  • 7200042 Compressor

  • 7200044 Transverse Connector Holder

  • 7200045 Transverse Connector Screwdriver

  • 7200048 Rod Cutter

  • 7200049 Caliper

  • 7200050 Torque Driver

  • 7200051 Gearshift Probe, Straight

  • 7200052 Gearshift Probe, Curved

  • 7200060 Screw Driver II

  • 7200061 Screwdriver III

  • 7200065 Lock Screw Guide

  • 7200066 Lock Screw Starter

  • 7200075 Distractor/Compressor Tip, Spherical

  • 7200076 Distractor/Compressor Tip Standard Right

  • 7200077 Distractor/Compressor Tip, Standard Left

  • 7200080 Distractor

  • 7200081 Distractor/Compressor Tip, Hook Right

  • 7200082 Distractor/Compressor Tip, Hook Left

  • 7200083 Distractor Offset Tip, Right

  • 7200084 Distractor Offset Tip, Left

  • 7200085 Compressor Offset Tip, Left

  • 7200086 Compressor Offset Tip, Right

  • 7200087 Distractor/Compressor Straight Hook, RT

  • 7200088 Distractor/Compressor Straight Hook, LT

  • 7200095 Persuader

  • 7200096 Persuader Lock Screw Driver

  • 7200501 K-Wire Short

  • 7200502 K-Wire, Long

  • 7201035 Cannulated Drill, °3.5mm

  • 7201040 Cannulated Drill, °4.0mm

  • 7201445:Macho Sólido 4,5mm

  • 7201455:Macho Sólido 5,5mm

  • 7201465:Macho Sólido 6,5mm

  • 7201475:Macho Sólido 7,5mm

  • 7201485:Macho Sólido 8,5mm

  • 7210031 Primary Insulator

  • 7210032 Secondary Insulator

  • 7210033 Third Insulator

  • 7230010 DBR® Instrument Tray

  • 7230023 Cannulated Awl

  • 7230030 DBR® Fixed Handle

  • 7230100 Dual Ball Rod Guide

  • 7230110 Dual Ball Rod Screwdriver Sleeve

  • 7230111 DBR® - Screwdriver Shaft

  • 7230115 DBR® Reattachment Tool

  • 7230117 DBR® - Blunt Dissector

  • 7230120 DBR® Rod Measurement Tool

  • 7230130 DBR® Lock Screw Driver

  • 7230135 DBR® Counter Torque Tool

  • 7230141 DBR® Tap Insulator

  • 7230142 DBR® Screw Insulator

  • 7230200 Split DBR® Guide

  • 7230205 DBR® Counter-Torque Tube

  • 7231045 4.5 mm Cannulated Tap

  • 7231055 5.5 mm Cannulated Tap

  • 7231065 6.5 mm Cannulated Tap

  • 7231075 7.5 mm Cannulated Tap

  • 7240001 SpheRx® II Instrument Tray 1

  • 7240002 SpheRx® II Instrument Tray 2

  • 7240003 SpheRx® II Implant Tray

  • 7240004 SpheRx® II Hook/Fixed Screw Tray

  • 7240010:Cabo Reto de Engate Rápido

  • 7240011:Probe Reto

  • 7240012:Probe Curvo

  • 7240013:Iniciador de Parafuso de Trava

  • 7240014:Chave de Redução Rocker.

  • 7240015:Pinça para Conector

  • 7240016:Chave de Conector

  • 7240019:Compressor

  • 7240020:Distrator/Conector Transversal Anel de Trava

  • 7240022:Retentor de Haste

  • 7240023:Empurrador de Haste

  • 7240024:Contra-torque

  • 7240025:Cabo Torque em T

  • 7240026:Medidor de Conector (anteriormente: GUIA)

  • 7240027:Camisa Média

  • 7240028:Camisa Grande

  • 7240029:Marcador de Pedículo, Esfera

  • 7240030:Marcador de Pedículo, Losango

  • 7240031:Segurador de Implante

  • 7240033:Medidor de Haste, 250mm

  • 7240034:Medidor de Haste, 500mm

  • 7240036:Dobrador de Haste In Situ

  • 7240037:Chave Retentora

  • 7240038:Chave Poliaxial

  • 7240039:Adaptador de Parafuso

  • 7240040:Ponta de Trava

  • 7240041:Cabo em T Engate Rápido

  • 7240042:Awl

  • 7240043:Awl Estreito

  • 7240044:Dobrador de Conector, Esquerdo

  • 7240045:Dobrador de Conector, Direito

  • 7240047:Probe Reto Estreito

  • 7240048:Redutor

  • 7240050:Ajustador de Cabeça de Parafuso

  • 7240051:Guia de Iniciador de Trava em T

  • 7240052 Hook Pusher

  • 7240053 Lamina Elevator

  • 7240054 Transverse Process Elevator

  • 7240055 Hook Inserter

  • 7240056 Fixed Head Screwdriver

  • 7240059:Probe Curvo Estreito

  • 7240060 Pedicle Elevator

  • 7240062 Straight Rod Holder

  • 7240062:Segurador Reto de Haste

  • 7240063 Lock Screw Starter, Straight

  • 7240074 SpheRx® II Rod Bender

  • 7240075 In-Situ Bender, Left

  • 7240079 Transverse Connector Driver

  • 7240081 Variable Transverse Connector Caddy

  • 7240082 Variable Transverse Connector Caddy Lid

  • 7240083 Variable Transverse Connector Tray Insrt

  • 7240084 SPII Transverse Connector Torque T-Handl

  • 7240085 SpheRx® II Reduction Screwdriver

  • 7240086 Reduction Counter Torque

  • 7240087 Reduction Screw Breakoff Tool

  • 7240089 SpheRx® II Reduction Screw Tray Base

  • 7240090 SpheRx® II Reduction Screw Tray Caddy

  • 7240091 SpheRx® II Reduction Screw Tray Nipple M

  • 7240145:SpheRx II Macho 4,5mm

  • 7240155:SpheRx II Macho 5,5mm

  • 7240165:SpheRx II Macho 6,5mm

  • 7240175:SpheRx II Macho 7,5mm

  • 7240185:SpheRx II Macho 8,5mm

  • 7247001 SpheRx® II MAS Screwdriver

  • 7247002 SpheRx® II MAS Compressor

  • 7247003 SpheRx® II MAS Distractor

  • 7247004 SpheRx® II MAS Rod Holder

  • 7247005 SpheRx® II MAS Persuader

  • 7247006 SpheRx® II MAS Counter Torque

  • 7247008 SpheRx® II MAS Instrument Tray, Base

  • 7247009 SpheRx® II MAS Instrument Tray, Insert

  • 7247010 SpheRx® II MAS Tray/TLIF Distractor Set

  • 7247011 SpheRx® II MAS Tray, Distractor Caddy L

  • 7247012 SpheRx® II MAS Instrument Tray, Lid

  • 7249001 SpheRx II Iliac Screw Tray Lid

  • 7249002 SpheRx II Iliac Screw Tray Base

  • 7249003 SpheRx II Iliac Screw Tray Insert

  • 7250060 Rod Measurement Tool

  • 7250062 Screw Adjuster

  • 7250063 Lock Screw Driver

  • 7250064 Lockscrew Starter

  • 7250065 SpheRx® II Anterior Polyaxial Screwdrive

  • 7250066 SpheRx® II Anterior Awl

  • 7250067 SpheRx® II Anterior Angled Awl

  • 7250068 Self-Centering Awl

  • 7250069 SpheRx® II Anterior Long Awl

  • 7250070 DRILL, 3.5mm

  • 7250072 Guide Sleeve

  • 7250073 SpheRx® II Anterior Depth Measurement To

  • 7250074 SpheRx® II Anterior Fixed Screwdriver

  • 7250077 SpheRx® II Anterior Pivoting Rod Holder

  • 7250078 SpheRx® II Anterior Rod Pusher

  • 7250079 SpheRx® II Anterior Compressor

  • 7250080 SpheRx® II Anterior Distractor

  • 7250081 SpheRx® II Anterior Counter Torque

  • 7250082 Lockscrew Starter Guide/Counter Torque

  • 7250083 Staple Inserter

  • 7250084 Anterior Guide Retainer

  • 7250085 Staple Inserter SpheRx®II Anterior

  • 7250089 Anterior Cross Connect Template

  • 7250090 Anterior Cross Connect Template

  • 7250091 Anterior Cross Connect Template

  • 7250092 Anterior Cross Connect Template

  • 7250093 Anterior Cross Connect Template

  • 7250094 Anterior Cross Connect Template

  • 7250095 SpheRx® II Anterior Staple Tamp

  • 7250097 Temporary Pin Inserter

  • 7250099 Compressor Block

  • 7250100 Anterior Cross Connect Template

  • 7250105 Anterior Cross Connect Driver

  • 7250106 DBR Counter-Torque Tool

  • 7250107 Cross Connect Inserter

  • 7250109 SpheRx® II Anterior Distractor Tips

  • 7250110 SpheRx® II Anterior Compressor/Distracto

  • 7250114 SPII Anterior Staple Caddy

  • 7250115 SPII Anterior Staple Caddy Lid

  • 7250116 SPII Anterior Single Hole Staple Caddy

  • 7250117 SPII Anterior Single Hole Staple Caddy L

  • 7250118 SPII Anterior Washer Caddy

  • 7250119 SPII Anterior Washer Caddy Lid

  • 7250120 SPII Anterior Cross Connect Caddy

  • 7250121 SPII Anterior Cross Connect Caddy Lid

  • 7250122 SPII Anterior Lockscrew Caddy

  • 7250123 SPII Anterior Lockscrew Caddy Lid

  • 7250124 SPII Anterior Polyaxial Screw Caddy

  • 7250125 SPII Anterior Fixed Screw Caddy

  • 7250126 SPII Anterior Tray Lid

  • 7250127 SPII Anterior Implant Tray Insert 1

  • 7250128 SPII Anterior Implant Tray Insert 2

  • 7250129 SPII Anterior Implant Tray Base

  • 7250130 SPII Anterior Instrument Tray 1 Insert 1

  • 7250131 SPII Anterior Instrument Tray 1 Insert 2

  • 7250132 SPII Anterior Instrument Tray 1 Base

  • 7250133 SPII Anterior Instrument Tray 2 Insert

  • 7250134 SPII Anterior Instrument Tray 2 Insert 2

  • 7250135 SPII Anterior Instrument Tray 2 Base

  • 7250345 Anterior Tap

  • 7250355 Anterior Tap

  • 7250365 Anterior Tap

  • 7250375 Anterior Ta

  • 7250526 Inferior Staple Guide, Small

  • 7250528 Inferior Staple Guide, Medium

  • 7250530 Inferior Staple Guide, Large

  • 7250626 Superior Staple Guide, Small

  • 7250628 Superior Staple Guide, Medium

  • 7250630 Superior Staple Guide, Large

  • 7270001 SpheRx® DBR® II Instrument Tray

  • 7270003 DBR® II Alternate Rod Delivery Tray

  • 7270010 DBR® II Counter-Torque/Reduction Tube

  • 7270011 DBR® II Reduction T-Handle

  • 7270013 DBR® II Guide

  • 7270014 DBR® II Reduction Extension

  • 7270015 Split DBR® II Non-Locking Guide

  • 7270016 DBR® II Rod Pusher

  • 7270017 DBR® II Tissue Dissector

  • 7270018 DBR® II Alternate Rod Inserter

  • 7270019 DBR® II Screwdriver

  • 7270020 DBR® II Rod Measurement Tool

  • 7270021 DBR® II Lock Screw Driver

  • 7270022 DBR II Lock Screw Starter

  • 7270023 Primary Insulator

  • 7270024 Tap Insulator

  • 7270025 Screw Insulator

  • 7270027 K-Wire Driver

  • 7270029 DBR® II Re-attachment tool

  • 7270031 DBR® II Non-Locking Guide

  • 7270032 Ratcheting Teardrop Handle

  • 7270034 DBR® Self-Retaining Screwdriver

  • 7270035 DBR® II Alternate Delivery Guide

  • 7270040 Curved Tissue Dissector

  • 7270043 Threaded Rod Pusher

  • 7270044 Counter-Torque Wrench

  • 7270045 Alternate Rod Pusher

  • 7270046 Non Locking Alternate Guide

  • 7270048 Rod Retrieval Tool

  • 7270049 Quick-Connect Straight Handle, Short

  • 7270050 Sphere Gripper, 30 Degree

  • 7270051 Sphere Gripper, 60 Degree

  • 7270054 DBR® II Compressor Arm, Short

  • 7270055 DBR® II Compressor Arm, Long

  • 7270056 DBR® II Compressor Rack

  • 7270057 DBR® II Cannulated Awl

  • 7270058 DBR® II Rod Holder

  • 7270059 DBR® II Single Level Reducer

  • 7270060 DBR® II Single Level Reducer Cap

  • 7270061 Constrained Rod Pusher

  • 7270080 Expandable Lockscrew Starter

  • 7270100 Blunt Tip K-Wire

  • 7270145 4.5mm Cannulated Tap

  • 7270155 5.5mm Cannulated Tap

  • 7270165 6.5mm Cannulated Tap

  • 7270175 7.5mm Cannulated Tap

  • 7270403 SpheRx DBR II Tray 2 Bottom Insert

  • 7770021 PPS Tray Lid

  • 7770022 SPX PPS Tray 5.5 Tulip/LS Caddy

  • 7770023 SPX PPS Tray 6.25 Tulip/LS Caddy

  • 7770024 SPX PPS Tray Cannulated Screw Caddy

  • 7770026 SPX PPS Tray Distractor Caddy

  • 7770027 SPX PPS Tray Top Level

  • 7770028 SPX PPS Tray Middle Level

  • 7770029 SPX PPS Tray Base

  • 7770030 SPX PPS Tray Nipple Mat

  • 7770031 SPX PPS Tray 5.5 Tulip Caddy Lid

  • 7770032 SPX PPS Tray 5.5 Lock Screw Caddy Lid

  • 7770033 SPX PPS Tray 6.25 Tulip Caddy Lid

  • 7770034 SPX PPS Tray 6.25 Lock Screw Caddy Lid

  • 7770035 SPX PPS Tray Distractor Caddy Lid

  • 7770036 SPX PPS Tray Pre-Assm Screwdriver Caddy

  • 7770037 SPX PPS Tray Protective Sleeve Caddy

  • 7770038 SPX PPS Tray Head Inserter Caddy

  • 7770040 SPX PPS Tray Protective Sleeve Caddy Lid

  • 7770050 SPX PPS Tray 5.5 Inst /Imp Base

  • 7770051 SPX PPS Tray Inst/Imp Top Level Insert

  • 7770052 SPX PPS Tray Inst/Imp Middle Insert

  • 7770053 SPX PPS Tray 6.25 Inst/Imp Base

  • 7770054 SPX PPS Pre-Assembly Loading Block

  • 7770056 SPX PPS Open Instrument Tray Base

  • 7771116 Compressor

  • 7771155 6.25mm PPS Threaded pusher

  • 7771157 Distractor Inserter

  • 7771160 Screw Head Adjuster 6.25mm Rod

  • 7771161 Screw Adjuster

  • 7771163 Assembled PPS Driver 6.25mm

  • 7771164 Tulip Reamer

  • 7771165 Lateral Tulip Reamer

  • 7771166 Posted Shankdriver

  • 7771167 Self-Retaining Shankdriver

  • 7771168 Pre-Assembly Tool

  • 7771169 Verification Torque T-Handle

  • 7771170 PPS Counter Torque

  • 7771171 Polyaxial Head Inserter 6.25mm ROD

  • 7771172 Head Inserter Insulator

  • 7771173 PPS Distractor

  • 7771174 Protective Sleeve

  • 7771175 Polyaxial Head Inserter 6.25mm

  • 7771176 Pre-Assembly Verification Tool

  • 7771177 Counter torque

  • 7771220 Distractor (10mm-20mm)

  • 7771230 Distractor (10mm-30mm)

  • 7771240 Distractor (10mm-40mm)

  • 7781155 5.5MM PPS Threaded Pusher

  • 7781160 Screw Head Adjuster 5.5mm Rod

  • 7781163 Assembled PPS Driver 5.5mm

  • 7781171 Polyaxial Head Inserter 5.5mm Rod

  • 7781175 Polyaxial Head Inserter 5.5mm

  • 7782005 PPS 5.5MM MAS Rod Inserter

  • 7782006 PPS 5.5MM MAS Rod Inserter T-H

  • 7782008 5.5MM PPS Rod Measurement Tool

  • 7782009 5.5MM PPS Rod Pusher

  • 7782010 5.5MM PPS Rod Holder

  • 7782011 5.5MM PPS Reattachment Tool

  • 7782012 SpheRx 5.5 MAS Lock Screw/Tulip Caddy

  • 7785050 SpheRx EXT Instrument Tray Base

  • 7785051 SpheRx EXT Instrument Tray Lid

  • 7785052 SpheRx EXT Instrument Top Tray

  • 7785053 SpheRx EXT Instrument Inserter Insert

  • 7785054 SpheRx EXT Instrument Bottom Tray Insert

  • 7785060 SpheRx EXT Implant Tray Lid

  • 7785061 SpheRx EXT Implant Top Tray

  • 7785062 SpheRx EXT Implant Tray Base

Instruções de Uso e Arquivos(1)

80074640003 - IFU Spherx II INSTR. V1.2022.pdf

INSTRUÇÕES DE USO OU MANUAL DO USUÁRIO DO PRODUTO

T1657618105/05/2022, 18:33Exp. 2677961229

A atualização destes documentos é executada pela empresa responsável pela regularização do produto.

Documentos Técnicos(1)

33395311030/05/2011

MATERIAL - Alteração/Inclusão/Exclusão de apresentação comercial em registro.

Publicado deferimento

Produtos relacionados

Fonte: Dados Abertos ANVISA + API Oficial ANVISA
Última atualização: 12 de Outubro de 2026
Ver na fonte oficial da ANVISA

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