INSTRUMENTAL PARA CORPECTOMIA NUVASIVE
Nome do produto
INSTRUMENTAL PARA CORPECTOMIA NUVASIVE
Número de registro
80074640034
Nome técnico
Classe de risco
I
Processo
25351319111201511
Razão social
Fabricante
País de fabricação
ESTADOS UNIDOS DA AMÉRICA
Apresentações / Modelos(317)
1008112 - K Medic Narrow Nose Pliers
1008113 - K Medic Mesh Pliers
1008750 - Mesh Cage Holder, 10.5" Straight
1008751 - Mesh Cage Holder, 10.5" Curved
1009202 - Universal Tamp, Autograft Straight
1009203 - Universal Tamp, Autograft Angled
1010410 - Mesh Inserter
1011442 - Mesh Plier Large
1011453 - Straight Mesh Positioner
1011454 - Mesh Positioner Left/Right
1011455 - Mesh Positioner Up/Down
1011535 - Sterilization Case, Mesh
1545186 - Tray Base, XLIF Corpectomy
1545187 - Top Insert, XLIF Corpectomy
1545188 - Middle Insert, XLIF Corpectomy
1545189 - Tray Lid, XLIF Corpectomy
1599102 - Generic 3-Level Tray, Base
3220210 - Maxcess III Fourth Blade
3223100 - 100mm Lung Retractor Blade Assembly - NA
3223110 - 110mm Lung Retractor Blade Assembly - NA
3223120 - 120mm Lung Retractor Blade Assembly - NA
3223130 - 130mm Lung Retractor Blade Assembly - NA
3223140 - 140mm Lung Retractor Blade Assembly - NA
3223150 - 150mm Lung Retractor Blade Assembly - NA
3223160 - 160mm Lung Retractor Blade Assembly - NA
3223170 - 170mm Lung Retractor Blade Assembly - NA
3223180 - 180mm Lung Retractor Blade Assembly - NA
3224100 - 100mm Lung Retractor Blade Assembly - WI
3224110 - 110mm Lung Retractor Blade Assembly - WI
3224120 - 120mm Lung Retractor Blade Assembly - WI
3224130 - 130mm Lung Retractor Blade Assembly - WI
3224140 - 140mm Lung Retractor Blade Assembly - WI
3224150 - 150mm Lung Retractor Blade Assembly - WI
3224160 - 160mm Lung Retractor Blade Assembly - WI
3224170 - 170mm Lung Retractor Blade Assembly - WI
3224180 - 180mm Lung Retractor Blade Assembly - WI
3230071 - Center Blade Extension Assy.
3230072 - Maxcess Left Arm Extension Assy
3230073 - Maxcess Right Arm Extension Assy
3230074 - Doyen - Left
3230075 - Doyen - Right
3230076 - Rib Removal Tool - Stille
3230077 - Rib Dissection Tool - Alexander
3230078 - Handle Assembly Lung Retractor
3230081 - Center blade extension assy.
3230082 - Maxcess Left Arm Extension Assy
3230083 - Maxcess Right Arm Extension Assy
3240014 - XLIF® Corpectomy Arm Ext, Left Short
3240015 - XLIF® Corpectomy Arm Ext, Right Short
3240016 - XLIF® Corpectomy Arm Ext, Center Short
3240017 - XLIF® Corpectomy Arm Ext, Left Long
3240018 - XLIF® Corpectomy Arm Ext, Right Long
3240019 - XLIF® Corpectomy Arm Ext, Center Long
5950003 - X-CORE Mini Inserter, Ø12mm
5950004 - X-CORE Mini Calipers
5950006 - X-CORE Mini Trial, Dual Core
5950007 - X-CORE Mini Trial, Dual Endcap
5950008 - X-CORE Mini Final Tightening Driver
5950009 - X-CORE Mini Graft Loading Tool
5950010 - X-CORE Mini Loading Block, Ø12mm
5950014 - X-CORE Mini Loading Block, Ø14mm
5954003 - X-CORE Mini Inserter, Ø14mm
5960001 - X-CORE Mini Trial, Ø14/Ø16 mm Dual End
5960002 - X-CORE Mini Endcap Trial, 17x14 Dual Ang
5960004 - X-CORE Mini SSCalipers
5960006 - X-CORE Mini Ti Trials, Core
5960007 - X-CORE Mini Trial, 15x12/17x14 Dual End
5960009 - X-CORE Mini SS Graft Loading Tool
5960010 - X-CORE Mini Trial, 17x14/19x16 Dual End
5960012 - X-CORE Mini Al Loading Block, Ø12mm
5960014 - X-CORE Mini Al Loading Block, Ø14mm
5960015 - X-CORE Mini SS Counter Torque, Ø14mm
5961001 - X-CORE Mini Base, Tray
5961002 - X-CORE Mini Tray, Top
5961003 - X-CORE Mini Tray, Middle
5961004 - X-CORE Mini Tray, Bottom
5961005 - X-CORE Mini Lid, Tray
5961022 - X-CORE Mini Caddy, Ø12mm Core Set Screw
5961023 - X-CORE Mini Caddy, Endcap Set Screw
5961024 - X-CORE Mini Caddy, Ø14mm Core Set Screw
5961122 - X-CORE Mini Lid, Ø12mm Set Screw Caddy
5961123 - X-CORE Mini Lid, Endcap Set Screw Caddy
5961124 - X-CORE Mini Lid, Ø14mm Set Screw Caddy
5961200 - X-CORE Mini SS Inserter, Ø12mm
5961400 - X-CORE Mini SS Inserter, Ø14mm
5961401 - VBR Mini Inserter, Ø14mm Angled 30°
5961403 - VBR Mini Driver, Ø14mm Angled 30°
5962000 - X-CORE Mini Tray, Ø12mm Core
5962001 - X-CORE Mini Caddy, Ø12mm Endcap
5962007 - X-CORE Mini SS Final Tightener
5962022 - VBR Mini Caddy, 12mm Core Set Screw
5962023 - VBR Mini Caddy, 12mm Core Endcap
5962024 - VBR Mini Caddy, Endcap Set Screw
5962101 - X-CORE Mini Lid, Ø12mm Endcap Caddy
5962122 - VBR Mini Caddy, 14mm Core Set Screw
5962123 - VBR Mini Caddy, 14mm Core Endcap
5962124 - VBR Mini Caddy, 14mm Core Angled Endcap
5963000 - X-CORE Mini Al Loading Block, Angled
5963001 - X-CORE Mini Caddy, Ø14mm Angled Endcap
5963101 - X-CORE Mini Lid, Ø14mm Ang Endcap Caddy
5964000 - X-CORE Mini Tray, Ø14mm Core
5964001 - X-CORE Mini Caddy, Ø14mm Endcap
5964101 - X-CORE Mini Lid, Ø14mm Endcap Caddy
6512018 - 18MM Manual Distraction Wrench
6512022 - 22MM Manual Distraction Wrench
6536130 - 16x30mm Trial
6536140 - 16x40mm Trial
6536150 - X-CORE 2 Endcap Trial, 16x50mm
6538130 - 18x30mm TRIAL
6538140 - 18x40mm TRIAL
6538150 - 18x50mm TRIAL
6538230 - 22x30mm Trial
6538240 - 22x40mm TRIAL
6538250 - 22x50mm TRIAL
6538260 - 22x60mm TRIAL
6538316 - X-CORE 2 Endcap Trial, 16mm Round
6538318 - X-CORE 2 Endcap Trial, 18mm Round
6538322 - 22mm ROUND TRIAL
6538326 - 26mm ROUND TRIAL
6538330 - 30mm ROUND TRIAL
6539003 - Small Lock Screw Driver
6539004 - Large Lock Screw Driver
6539005 - Torque Handle
6539006 - Teardrop Handle
6539007 - Set Screw Driver
6539008 - X-Core Distractor
6539009 - Cylinder Tamp
6539010 - Graft Impactor
6539011 - Graft Spatula
6539013 - Endcap Tamp
6539014 - Core Tamp 18
6539015 - Core Tamp 22
6539018 - Trial Inserter Assy Vbr
6539020 - lid, xlif vbr instrument tray
6539021 - Base, XLIF VBR Instrument Tray
6539022 - Insert, XLIF VBR Instrument Tray
6539026 - LID, XLIF VBR 18mm Implant Tray
6539027 - Base, XLIF VBR 18mm Implant Tray
6539028 - Insert, XLIF VBR 18mm Implant Tray
6539036 - Implant Loading Block Size 18mm
6539037 - Implant Loading Block Size 22mm
6539040 - Lock Screw Caddy, XLIF VBR 18mm Imp Tra
6539041 - Implant Caddy, XLIF VBR 18mm Imp Tray
6539056 - Small Lock Screw Driver
6539057 - Large Lock Screw Driver
6539058 - Small Lock Screw Driver Bracket
6539060 - Trial Inserter Assy Expandable
6539061 - Inserter Removal Tool
6539118 - 18mm VBR Implant Inserter
6539122 - 22mm VBR Implant Inserter
6539216 - X-CORE 2 Core Tamp, Ø16mm
6539218 - X-CORE 2 Core Tamp, Ø18mm
6539222 - X-CORE 2 Core Tamp, Ø22mm
6549016 - X-CORE 2 Cylinder Tamp, 16mm
6549218 - X-CORE 2 Cylinder Tamp, 18mm
6549222 - X-CORE 2 Cylinder Tamp, 22mm
6559118 - X-CORE VBR Inserter, 18mm Dismantlable
6559122 - X-CORE VBR Inserter, 22mm Dismantlable
6590201 - Adjustable VBR Trial Inserter Assembly 0
6590202 - Adjustable VBR Trial Inserter Assembly 4
6590203 - ADJUSTABLE VBR TRIAL INSERTER ASSEMBLY 8
6590204 - ADJUSTABLE VBR TRIAL INSERTER ASSEMBLY 1
6590206 - Adjustable VBR Caliper
6590207 - Adjustable VBR Distractor
6590208 - Adjustable VBR Lock Screw Driver
6590210 - VBR COBB ASSEMBLY - 18 mm
6590211 - XLIF® Corpectomy Cobb, 22mm
6590212 - VBR Cobb Assembly - 24 mm
6590213 - VBR Cobb ASSEMBLY - 26 mm
6590214 - VBR Cobb ASSEMBLY - 30 mm
6590218 - Inserter/Distractor - 18mm Core
6590222 - Inserter/Distractor - 22mm Core
6590223 - Leksell, Large
6590224 - Leksell, Medium
6590225 - Leksell, Small
6590231 - VBR Osteotome 15 mm
6590233 - VBR Osteotome 25 mm
6590234 - Rotating Kerrison Handle
6590235 - Kerrison Shaft - 3MM
6590236 - Kerrison Shaft - 5MM
6591130 - Adjustable VBR Endcap Trial 18x30
6591140 - Adjustable VBR Endcap Trial 18x40
6591240 - Adjustable VBR Endcap Trial 22x40
6591250 - Adjustable VBR Endcap Trial 22x50
6591255 - Adjustable VBR Endcap Trial 22x55
6592130 - Adjustable VBR Asym Endcap Trial 18x30
6592140 - Adjustable VBR Asym Endcap Trial 18x40
6592240 - Adjustable VBR Asym Endcap Trial 22x40
6592250 - Adjustable VBR Asym Endcap Trial 22x50
6592255 - Adjustable VBR Asym Endcap Trial 22x55
6593122 - Adjustable VBR Round Endcap Trial 22mm
6593124 - Adjustable VBR Round Endcap Trial 24mm
6593226 - Adjustable VBR Round Endcap Trial 26mm
6593230 - Adjustable VBR Round Endcap Trial 30mm
6593233 - Adjustable VBR Round Endcap Trial 33mm
6650002 - X-CORE Mini Calipers, X-CORE
6650003 - X-CORE 2 Height Caliper
6650004 - X-CORE 2 Distractor
6651004 - X-CORE 2 Distracter, Ø16mm
6652004 - X-CORE 2 Ø16mm Distractor (Long)
6790153 - COUNTER TORQUE HANDLE
6900070 - Straight Curette, 2mm Thoracic
6900071 - Up Angled Curette, 2mm Thoracic
6900072 - Down Facing Curette, 2mm Thoracic
6900132 - Kerrison Rongeur, 2mm
6900322 - Endplate Scraper Push/Pull Small- Down
6900341 - Serrated rasp- Thoracic
6900429 - Pituitary Rongeur, Small
6904401 - Universal Broach, 6x18mm Angled
6904402 - Universal Broach, 8x18mm Angled
6904403 - Universal Broach, 10x18mm Angled
6904414 - Universal Rongeur, Med Angled Right
6904415 - Universal Rongeur, Med Angled Left
6904416 - Universal Rongeur, Angled Right Large
6904417 - Universal Rongeur, Angled Left Large
6904420 - Universal Cobb, Angled Up Small
6904421 - Universal Cobb, Angled Down Small
6904424 - Angled Cobb Assy.Up, Large
6904425 - Angled Cobb Assy.Down, Large
6904432 - Universal Curette, Angled Up Medium
6904433 - Universal Curette, Angled Down Medium
6904460 - Angled Endplate Scraper, Assy.
6904470 - Angled Rasp Assembly
6904480 - Universal Tamp, XLIF® Implant Angled
6904485 - Universal Inserter, Angled XL
6904492 - XLIF Angled Instruments - Base
6904493 - XLIF Angled Instruments - Top Tray
6904494 - XLIF Angled Instruments - Middle Tray
6910608 - 8x22x60mm COR XL Wide - Trial
6910610 - 10x22x60mm COR XL Wide - Trial
6910612 - 12x22x60mm COR XL Wide - Trial
7110002 - X-CORE II Set Screw Driver
7110004 - X-CORE II Silicone Handle
7110010 - Ti Surgical Mesh Cutter
7110012 - X-CORE 2 Screw Driver, Endcap Lock
7161000 - X-CORE Mini Inserter, Ø16mm
7161001 - X-CORE 2 Core Trial, Ø16mm
7161004 - X-CORE 2 Implant Loading Block, Ø16mm
7162016 - X-CORE 2 Inserter Slap Hammer Attachment
7165100 - VBR 2 SS Inserter, Ø16mm
7165200 - X-CORE 2 Expander, 16mm Gearless Manual
7181000 - X-CORE Mini Inserter, Ø18mm
7181001 - X-CORE II Trial, Ø18mm
7181002 - X-CORE II Implant Loading Block, 18mm
7181003 - X-CORE II Implant Loading Block, 22mm
7181004 - X-CORE 2 Impant Loading Block, Ø18mm
7183004 - X-CORE 2 Nipple Mat, Ø18mm
7183005 - X-CORE 2 Base, Univ Lock Screw Caddy
7183006 - X-CORE 2 Base, Screw Caddy Ø18/Ø22mm
7183009 - X-CORE 2 Silicone Mat, Ø18/Ø22mm
7183105 - X-CORE 2 Lid, Univ Lock Screw Caddy
7183106 - X-CORE 2 Lid, Screw Caddy Ø18/Ø22mm
7185100 - VBR 2 SS Inserter, Ø18mm
7185200 - X-CORE 2 Expander, 18mm Gearless Manual
7221000 - X-CORE Mini Inserter, Ø22mm
7221001 - X-CORE II Trial, Ø22mm
7221004 - X-CORE 2 Implant Loading Block, Ø22mm
7223001 - X-CORE 2 Top Tray, Ø22mm
7223002 - X-CORE 2 Middle Tray, Ø22mm
7223003 - X-CORE 2 Bottom Tray, Ø22mm
7223007 - X-CORE 2 Side Tray Name Tag, Ø22mm
7223008 - X-CORE 2 Front Tray Name Tag, Ø22mm
7225100 - X-Core II SS Inserter, Ø22mm
7225200 - X-CORE 2 Expander, 22mm Gearless Manual
7240010 - Universal Quick Conn, Straight Handle
7240041 - Universal T-Handle, Quick Connect
7250068 - Self-Centering Awl
7250070 - Universal Drill, 3.5mm
7250073 - SpheRx® II Anterior Depth Measurement To
7250355 - Anterior Tap
7250365 - Anterior Tap
7250375 - Anterior Tap
7418106 - CoRoent® XL Annulus Cutter, 6x18mm
7418108 - CoRoent® XL Annulus Cutter, 8x18mm
7422106 - CoRoent® XL Annulus Cutter, 6x22mm
7422108 - CoRoent® XL Annulus Cutter, 8x22mm
7810042 - Lock Nut Retainer
7820003 - Single Barrel Guide Inf Assy
7820004 - Single Barrel Guide - Superior
7820005 - Double Barrel Guide - Inferior
7820006 - Double Barrel Guide - Superior
7820009 - Provisional Lock Nut Tightener
7820011 - Guide Removal Tool
7820013 - Traverse Screwdriver
7820014 - Traverse Pin, Fixation Temporary
7820016 - Self Retaining Lock Nut Starter
7820017 - Counter Torque
7820018 - Torque T-Handle
7820019 - Traverse Compressor
7820021 - Caliper
7820022 - Dilator
7820023 - Traverse Distractor
7820024 - Plate Inserter
7820026 - Retainer
7820027 - Spiked Guide Retainer
7820028 - Anterior Awl
7820029 - Bolt Driver
7820031 - Traverse Plate Inserter, Pivoting
7820032 - Telescoping Bolt Guide
7820033 - Single Bolt Guide, Superior
7820034 - Single Bolt Guide, Superior
7820036 - Centering Sleeve
7820037 - Distractor Tip
7830010 - Traverse Plate System (LID)
7830011 - Traverse Plate System (Bottom Ins Tray)
7830012 - Traverse Plate System (Top Ins Tray)
7830013 - Traverse Plate System (Middle Ins Tray)
7830014 - Traverse Plate System (Bone Screw Caddy)
7830015 - Traverse Plate System (Bolt Caddy)
7830016 - Traverse Plate System (Lock Nut Caddy)
7830017 - Traverse Plate System (Lock Nut Lid)
7830018 - Traverse Plate System (Fixed Plates)
7830019 - Traverse Plate System (Compress Plates)
7830020 - Traverse Plate System (Bottom Imp Tray)
7830021 - Traverse Plate System (Bottom Imp Tray)
8801300 - Generic NuVasive Tray Lid
8801333 - Generic NuVasive Tray Lid
Instruções de Uso e Arquivos(1)
| Código | Tipo | Arquivo | Expedição | Expediente |
|---|---|---|---|---|
| T16602525 | INSTRUÇÕES DE USO OU MANUAL DO USUÁRIO DO PRODUTO | 80074640034 - IFU X Core Instr V1.2022.pdf | 10/05/2022, 18:04 | 2702632220 |
INSTRUÇÕES DE USO OU MANUAL DO USUÁRIO DO PRODUTO
A atualização destes documentos é executada pela empresa responsável pela regularização do produto.
Documentos Técnicos(1)
| Petição / Protocolo | Data | Assunto | Situação |
|---|---|---|---|
| 3046732212 | 09/08/2021 | MATERIAL - Retificação – Correção pela ANVISA | Publicado deferimento |
MATERIAL - Retificação – Correção pela ANVISA
Publicado deferimento
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