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Instrumental System for Surgical Treatment - Argentina Medical Device Registration

Access comprehensive regulatory information for Instrumental System for Surgical Treatment in the Argentina medical device market through Pure Global AI's free database. This Revalidation of Registration I-II-III-IV medical device is registered with Argentina's ANMAT (National Administration of Drugs, Food and Medical Technology). The device was registered on June 08, 2024.

This page provides complete registration details including product code (16-972), brand name (Synthes), authorized representative information, registration type, and regulatory compliance data from the official Argentina ANMAT medical device database. Pure Global AI offers free access to Argentina's medical device registry, helping global MedTech companies navigate Argentina regulations efficiently.

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Argentina ANMAT Data
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Revalidation of Registration I-II-III-IV
Instrumental System for Surgical Treatment
Sistema Instrumental para tratamiento quirúrgico
Argentina Medical Device Registration
Pure Global
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Product Information

Fabr.1 and 2 05.001.099 Maintenance Appliance, for EPD+APD 05.001.101 EPD Handle Adapter for Spray-Maintenance Fabr.1 and 4 05.001.064 Adapter for maintenance device, for EPD and APD 03.000.305S Leaf Saw 31*10*0.38 p/saw sag 03.000.306S Leaf Saw 22*12*0.38 p/saw sag 03.000.307S 15*16*0.38 p/saw saw sag 03.000.308S Leaf Saw 27*6*0.6 p/saw sag 03.000.309S Leaf Saw 27*10*0.6 p/saw sag 03.000.310S Leaf Saw 27*14*0.6 p/saw sag 03.000.311 Leaf sawing 26.5*13.3*0.6 1/2lunar 03.000.311S Leaf Saw 26.5*13.3*0.6 1/2 Lunar 03.000.312 Leaf 25*16.3*0.6 1/2 lunar 03.000.312S Leaf Saw 25*16.3*0.6 1/2 Lunar 03.000.313 Leaf saw 30*17.9*0.6 1/2 lunar 03.000.313S Leaf Saw 30*17.9*0.6 1/2 Lunar 03.000.314S Leaf Saw 18*2.5*0.38 p/saw sag 03.000.315S Leaf Saw 43*20*0.6 p/saw sag 03.000.316 Leaf 30*21.9*0.6 1/2 lunar 03.000.316S Leaf Saw 30*21.9*0.6 1/2 Lunar 03.000.320S Leaf Saw 13*6.4/2.9*0.6 Trapezoidal P/S 03.000.321S Leaf-sawn 20*6.4/2.9*0.6 trapezoidal p/s 03.000.322S 7*4*0.6 p/saw saw 03.000.323S Leaf saw 14*6.4*0.6 p/saw alter 03.000.324S Leaf 14.5*4*0.6 p/alter saw 03.000.325S Leaf Saw 25*5.5*0.6 p/saw alter p/rh 03.000.326S Leaf saw 27*6.4*0.6 p/saw alter 03.000.327S Leaf Saw 27*6.4/2.9*0.6 Trapezoidal P/S 03.000.328S Leaf Saw 33.5*6.4*0.6 p/saw alter 03.000.329S Leaf Saw 34.5*5/2.5*0.6 1/2Moon Rising 03.000.330S Leaf Saw 33.5*6.4*0.6 Displacement Towards 03.000.331S Leaf Cutter 33.5*6.4*0.6 w/offset a 03.000.332S Leaf Sawing 33.5*6.4*0.6 w/offset to 03.000.334 Leaf-sawn 20*6.4/2.9*0.6 trapezoidal lar 03.000.334S Leaf-sawing 20*6.4/2.9*0.6 trapezoidal lar 03.000.335 Leaf-sawn 27*6.4/2.9*0.6 trapezoidal lar 03.000.335S Leaf Saw 27*6.4/2.9*0.6 Trapezoidal Lar 03.000.336 Leaf saw 13*3*0.4 p/saw alter 03.000.336S Leaf saw 13*3*0.4 p/saw alter 03.000.337 Leaf sawing 20*3*0.4 p/alter saw 03.000.337S Leaf saw 20*3*0.4 p/saw alter 03.000.338 Leaf saw 9.2*7.3*0.6 p/osteotomy-edge 03.000.338S Leaf Saw 9.2*7.3*0.6 p/Osteotomy-Edge 03.000.339 Leaf Sawing 9.2*7.3*0.6 p/osteotomy-edge 03.000.339S Leaf Saw 9.2*7.3*0.6 p/Osteotomy-Edge 03.000.340 Leaf Saw Angle-105° 7*11.5*0.4 Body 7 03.000.340S Leaf Saw Angle-105° 7*11.5*0.4 Body 7 03.000.341 Leaf Saw Angle-105° 12*11.5*0.4 Body 03.000.341S Leaf Saw Angle-105° 12*11.5*0.4 Body 03.000.342 Leaf angle 105° 12*9.5*0.4 body 7 03.000.342S Leaf Saw Angle-105° 12*9.5*0.4 Body 7 03.000.343 Leaf Saw Angle-105° 12*4.5*0.4 Body 7 03.000.343S Leaf Saw Angle-105° 12*4.5*0.4 Body 7 Fabr.1 and 3 03.000.360 Scraper for alternating saw 11*5 rectif 03.000.360S Scraper for alternating saw 11*5 rectif 03.000.361 Scraper for alternating saw 14*5 rectif 03.000.361S Scraper for alternating saw 14*5 rectif 03.000.362 Scraper for alternating saw 11*5 rectif 03.000.362S Scraper for alternating saw 11*5 rectif 03.000.363 Scraper for alternating saw 14*7 rectif 03.000.363S Scraper for alternating saw 14*7 rectif 03.000.364 Reamer for small prox alternating saw 03.000.364S Reamer for alternating saw small prox 03.000.365 Reamer for small dist alternating saw 03.000.365S Reamer for alternating saw small dist 03.000.376 Broc ¢1.1 w/top L31.5/18 2 artist-cut 03.000.376S Broc ¢1.5 w/top L19.5/6 2 artist-cut 03.000.377 Broc ¢1.5 w/top L19.5/6 2 artist-cut 03.000.377S Broc ¢1.5 w/top L19.5/6 2 artist-cut 03.000.379 Broc ¢1.5 w/top L31.5/18 2 artist-cut 03.000.379S Broc ¢1.5 w/top L31.5/18 2 artist-cut 03.000.383 Broc ¢2 w/top L31.5/18 2 artist-cut 03.000.383S Broc ¢2 w/top L31.5/18 2 artist-cut 03.000.384 Broc ¢1 w/top L31.5/18 2 artist-cut 03.000.384S Broc ¢1 w/top L31.5/18 2 artist-cut 05.001.178.01S Irrigation pipe set, p/EPD and APD 05.011.179.05S Clips for irrigation pipe set, pack of 5 units Fab. 1 and 2 03.000.350 Trepanation milling cutter 7.0mm 03.000.350S Milling-trepaning 7.0mm 03.000.351 Trepanation Milling Cutter 12.0mm 03.000.351S Milling cutter 12.0mm 05.001.002 Basic console, for EPD & SED 05.001.006 Standard console, p/EPD & SED 05.001.010 Electric Pen Drive 60'000 rpm 05.001.012 Trigger for EPD 05.001.016 Pedal Switch (1ped.), p/Electric Pen Drive 05.001.021 EPD & SED Cable - Console, L 4m 05.001.022 Console pedal cable for EPD L4m 05.001.025 EPD & SED Cable - Console, L 3m 05.001.027 Nozzle-closure for cable for Electric Pen D. 05.001.028 Screw adapter, w/quick anchor AO/ASIF 05.001.029 Screw adapter, w/hexagonal anchor; 05.001.030 Adapter w/dental anchor: 05.001.031 Adapter w/J-Latch anchor; 05.001.032 AO/ASIF Adapter 05.001.033 45° Oscillating Drilling Adapter 05.001.034 Screw adapter w/dental anchor; 05.001.035 Short 90° Adapter, p/EPD+APD 05.001.036 Long-90° Dental Anchor Adapter for EPD 05.001.037 Kirschner needle adapter, for EPD+APD 05.001.038 Oscillating Saw Adapter 05.001.039 Sagittal Saw Adapter 05.001.040 Alternating Saw Adapter 05.001.044 AO/ASIF 45° p/EPD+APD adapter 05.001.045 Milling Adapter, S: 05.001.046 Milling Adapter, M: 05.001.047 Milling Adapter, L: 05.001.048 Milling Adapter, S, Angled 05.001.049 Milling Adapter, M, Angled 05.001.050 Milling Adapter, L, Angled 05.001.051 Arc-protection S for EPD+APD for adapter 05.001.052 Arc-protection M for EPD+APD for adapter 05.001.054 Drill bit adapter, p/EPD+APD 05.001.055 Milling adapter 20° p/EPD+APD 05.001.059 Craniotome Adapter 05.001.063 Milled adapter, XL, 20°, p/EPD and APD 05.001.065 Cooling nozzle, p/EPD and APD 05.001.066 Short irrigation nozzle, for EPD+APD 05.001.067 Medium irrigation nozzle, for EPD+APD 05.001.068 Long irrigation nozzle, for EPD+APD 05.001.070 Irrigation nozzle, p/ref. 05.001.039, p/EPD+APD 05.001.071 Irrigation nozzle, p/ref. 05.001.040, p/EPD+APD 05.001.074 Handle for shift-instr for EPD/A adapters 05.001.076 Cooling nozzle, for EPD+APD 05.001.103 Adapter for Intra anchorage, for EPD and APD 05.001.111 Nozzle-irrigation for EPD+APD for adapters 05.001.120 45° Adapter, Cannulated, w/Mandrel Three Jaws 05.001.121 Guide for Kirschner needle, for oscillating saw 05.001.122 Cooling nozzle, p/EPD and APD, P/05.001.055 05.001.123 Milled, straight, p/EPD and APD adapter 05.001.177 Drill with Hudson Anchor, p/EPD & APD 05.001.180 Cooling nozzle, p/perf. w/Hundson Anchor 05.001.182 Sagittal Saw Adapter, 90°, p/EPD and APD 05.001.183 Sagittal Saw Adapter, Centering, p/EPD & APD 05.001.184 Irrigation nozzle, p/ref 05.001.182, p/EPD+APD 05.001.185 Irrigation nozzle, p/ref 05.001.183, p/EPD+APD 310.932 Replacement key

Spanish:

Fabr.1 y 2 05.001.099 Aparato mantenimiento, p/EPD+APD 05.001.101 Adaptador p/mango EPD p/spray-mantenimie Fabr.1 y 4 05.001.064 Adaptador p/aparato mantenimiento, p/EPD y APD 03.000.305S Hoj-sierr 31*10*0.38 p/sierra sag 03.000.306S Hoj-sierr 22*12*0.38 p/sierra sag 03.000.307S Hoj-sierr 15*16*0.38 p/sierra sag 03.000.308S Hoj-sierr 27*6*0.6 p/sierra sag 03.000.309S Hoj-sierr 27*10*0.6 p/sierra sag 03.000.310S Hoj-sierr 27*14*0.6 p/sierra sag 03.000.311 Hoj-sierr 26.5*13.3*0.6 ½lunar 03.000.311S Hoj-sierr 26.5*13.3*0.6 ½lunar 03.000.312 Hoj-sierr 25*16.3*0.6 ½lunar 03.000.312S Hoj-sierr 25*16.3*0.6 ½lunar 03.000.313 Hoj-sierr 30*17.9*0.6 ½lunar 03.000.313S Hoj-sierr 30*17.9*0.6 ½lunar 03.000.314S Hoj-sierr 18*2.5*0.38 p/sierra sag 03.000.315S Hoj-sierr 43*20*0.6 p/sierra sag 03.000.316 Hoj-sierr 30*21.9*0.6 ½ lunar 03.000.316S Hoj-sierr 30*21.9*0.6 ½ lunar 03.000.320S Hoj-sierr 13*6.4/2.9*0.6 trapezoidal p/s 03.000.321S Hoj-sierr 20*6.4/2.9*0.6 trapezoidal p/s 03.000.322S Hoj-sierr 7*4*0.6 p/sierra alter 03.000.323S Hoj-sierr 14*6.4*0.6 p/sierra alter 03.000.324S Hoj-sierr 14.5*4*0.6 p/sierra alter 03.000.325S Hoj-sierr 25*5.5*0.6 p/sierra alter p/rh 03.000.326S Hoj-sierr 27*6.4*0.6 p/sierra alter 03.000.327S Hoj-sierr 27*6.4/2.9*0.6 trapezoidal p/s 03.000.328S Hoj-sierr 33.5*6.4*0.6 p/sierra alter 03.000.329S Hoj-sierr 34.5*5/2.5*0.6 1/2lun ascendente 03.000.330S Hoj-sierr 33.5*6.4*0.6 dislocamiento hac 03.000.331S Hoj-sierr 33.5*6.4*0.6 c/compensación a 03.000.332S Hoj-sierr 33.5*6.4*0.6 c/compensación a 03.000.334 Hoj-sierr 20*6.4/2.9*0.6 trapezoidal lar 03.000.334S Hoj-sierr 20*6.4/2.9*0.6 trapezoidal lar 03.000.335 Hoj-sierr 27*6.4/2.9*0.6 trapezoidal lar 03.000.335S Hoj-sierr 27*6.4/2.9*0.6 trapezoidal lar 03.000.336 Hoj-sierr 13*3*0.4 p/sierra alter 03.000.336S Hoj-sierr 13*3*0.4 p/sierra alter 03.000.337 Hoj-sierr 20*3*0.4 p/sierra alter 03.000.337S Hoj-sierr 20*3*0.4 p/sierra alter 03.000.338 Hoj-sierr 9.2*7.3*0.6 p/osteotomía-borde 03.000.338S Hoj-sierr 9.2*7.3*0.6 p/osteotomía-borde 03.000.339 Hoj-sierr 9.2*7.3*0.6 p/osteotomía-borde 03.000.339S Hoj-sierr 9.2*7.3*0.6 p/osteotomía-borde 03.000.340 Hoj-sierr angul-105° 7*11.5*0.4 cuerpo 7 03.000.340S Hoj-sierr angul-105° 7*11.5*0.4 cuerpo 7 03.000.341 Hoj-sierr angul-105° 12*11.5*0.4 cuerpo 03.000.341S Hoj-sierr angul-105° 12*11.5*0.4 cuerpo 03.000.342 Hoj-sierr angul-105° 12*9.5*0.4 cuerpo 7 03.000.342S Hoj-sierr angul-105° 12*9.5*0.4 cuerpo 7 03.000.343 Hoj-sierr angul-105° 12*4.5*0.4 cuerpo 7 03.000.343S Hoj-sierr angul-105° 12*4.5*0.4 cuerpo 7 Fabr.1 y 3 03.000.360 Raspador p/sierra alternante 11*5 rectif 03.000.360S Raspador p/sierra alternante 11*5 rectif 03.000.361 Raspador p/sierra alternante 14*5 rectif 03.000.361S Raspador p/sierra alternante 14*5 rectif 03.000.362 Raspador p/sierra alternante 11*5 rectif 03.000.362S Raspador p/sierra alternante 11*5 rectif 03.000.363 Raspador p/sierra alternante 14*7 rectif 03.000.363S Raspador p/sierra alternante 14*7 rectif 03.000.364 Escariador p/sierra alternante peq prox 03.000.364S Escariador p/sierra alternante peq prox 03.000.365 Escariador p/sierra alternante peq dist 03.000.365S Escariador p/sierra alternante peq dist 03.000.376 Broc ¢1.1 c/top L31.5/18 2 artist-corte 03.000.376S Broc ¢1.5 c/top L19.5/6 2 artist-corte 03.000.377 Broc ¢1.5 c/top L19.5/6 2 artist-corte 03.000.377S Broc ¢1.5 c/top L19.5/6 2 artist-corte 03.000.379 Broc ¢1.5 c/top L31.5/18 2 artist-corte 03.000.379S Broc ¢1.5 c/top L31.5/18 2 artist-corte 03.000.383 Broc ¢2 c/top L31.5/18 2 artist-corte 03.000.383S Broc ¢2 c/top L31.5/18 2 artist-corte 03.000.384 Broc ¢1 c/top L31.5/18 2 artist-corte 03.000.384S Broc ¢1 c/top L31.5/18 2 artist-corte 05.001.178.01S Juego tubos irrigación, p/EPD y APD 05.011.179.05S Clips p/juego tubos irrigación, envase 5 unidades Fab. 1 y 2 03.000.350 Fresa-trepanacion 7.0mm 03.000.350S Fresa-trepanacion 7.0mm 03.000.351 Fresa-trepanacion 12.0mm 03.000.351S Fresa-trepanacion 12.0mm 05.001.002 Consola básica, p/EPD & SED 05.001.006 Consola estándar, p/EPD & SED 05.001.010 Electric Pen Drive 60'000 rpm 05.001.012 Gatillo p/EPD 05.001.016 Pedal interruptor (1ped.), p/Electric Pen Drive 05.001.021 Cable p/EPD & SED – Consola, L 4m 05.001.022 Cable pedal consola p/EPD L4m 05.001.025 Cable p/EPD & SED – Consola, L 3m 05.001.027 Boquilla-cierre p/cable p/Electric Pen D. 05.001.028 Adaptador tornillos, c/anclaje ráp. AO/ASIF 05.001.029 Adaptador tornillos, c/anclaje hexagonal; 05.001.030 Adaptador c/anclaje dental: 05.001.031 Adaptador c/anclaje J-Latch; 05.001.032 Adaptador AO/ASIF 05.001.033 Adaptador perforación oscilante 45° 05.001.034 Adaptador de tornillos c/anclaje dental; 05.001.035 Adaptador corto 90°, p/EPD+APD 05.001.036 Adaptador largo-90° anclaje-dental p/EPD 05.001.037 Adaptador de agujas Kirschner, p/ EPD+APD 05.001.038 Adaptador de sierra oscilante 05.001.039 Adaptador de sierra sagital 05.001.040 Adaptador de sierra alternante 05.001.044 Adaptador AO/ASIF 45° p/EPD+APD 05.001.045 Adaptador de fresado, S: 05.001.046 Adaptador de fresado, M: 05.001.047 Adaptador de fresado, L: 05.001.048 Adaptador de fresado, S, Angulado 05.001.049 Adaptador de fresado, M, Angulado 05.001.050 Adaptador de fresado, L, Angulado 05.001.051 Arco-protección S p/EPD+APD p/adaptador 05.001.052 Arco-protección M p/EPD+APD p/adaptador 05.001.054 Adaptador de trépanos, p/EPD+APD 05.001.055 Adaptador-fresado 20° p/EPD+APD 05.001.059 Adaptador craneótomo 05.001.063 Adaptador fresado, XL, 20°, p/EPD Y APD 05.001.065 Tobera refrigeración, p/EPD y APD 05.001.066 Tobera irrigación corta, p/EPD+APD 05.001.067 Tobera irrigación mediana, p/EPD+APD 05.001.068 Tobera irrigación larga, p/EPD+APD 05.001.070 Tobera irrigación, p/ref. 05.001.039, p/EPD+APD 05.001.071 Tobera irrigación, p/ref. 05.001.040, p/EPD+APD 05.001.074 Mango p/cambio-instr p/adaptadores EPD/A 05.001.076 Tobera refrigeración, p/ EPD+APD 05.001.103 Adaptador p/anclaje Intra, p/EPD Y APD 05.001.111 Tobera-irrigación p/EPD+APD p/adaptadores 05.001.120 Adaptador 45°, canulado, c/mandril tres mordazas 05.001.121 Guía p/aguja Kirschner, p/sierra oscilante 05.001.122 Tobera refrigeración, p/EPD y APD, P/05.001.055 05.001.123 Adaptador fresado, recto, p/EPD y APD 05.001.177 Perforadora c/anclaje Hudson, p/EPD y APD 05.001.180 Tobera refrigeración, p/perf. c/anclaje Hundson 05.001.182 Adaptador de sierra sagital, de 90°, p/EPD y APD 05.001.183 Adaptador de sierra sagital, centrado, p/EPD y APD 05.001.184 Tobera de irrigación, p/ref 05.001.182, p/EPD+APD 05.001.185 Tobera de irrigación, p/ref 05.001.183, p/EPD+APD 310.932 Llave recambio

Device Classification
Registration Type
Revalidation of Registration I-II-III-IV
Reválida de Registro I-II-III-IV
Product Code
16-972
Brand Name
Synthes
Product Name
Instrumental System for Surgical Treatment
Sistema Instrumental para tratamiento quirúrgico
Registration Information
Registration Date
June 08, 2024
Database ID
cmhayu5bi0ktuekuzytqrke97
Authorized Representative