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Implant for fixation of cranial fractures. - Argentina Medical Device Registration

Access comprehensive regulatory information for Implant for fixation of cranial fractures. in the Argentina medical device market through Pure Global AI's free database. This Registration Class III-IV medical device is registered with Argentina's ANMAT (National Administration of Drugs, Food and Medical Technology). The device was registered on May 13, 2024.

This page provides complete registration details including product code (669-382), brand name (Osteonic), 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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Registration Class III-IV
Implant for fixation of cranial fractures.
Implante de fijación de fracturas craneales.
Argentina Medical Device Registration
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Product Information

• Optimus CMF System. Descripción: Sistema de cirugía maxilofacial y mandibular no estéril Articulo: NST304L02A Straight Plate, Long, 2Hole 3.4x12.4mm/0.4mm NST304X02A Straight Plate, Extra, 2Hole 3.4x15.4mm/0.4mm NST304L04A Straight Plate, Middle, 4Hole 3.4x21.4mm/0.4mm NST304X04A Straight Plate, Extra, 4Hole 3.4x24.4mm/0.4mm NST304M05A Straight Plate, Middle, 5Hole 3.4x21.4mm/0.4mm NST304M06A Straight Plate, Middle, 6Hole 3.4x25.9mm/0.4mm NST304M10A Straight Plate, Middle, 10Hole 3.4x43.9mm/0.4mm NST304M20A Straight Plate, Middle, 20Hole 3.4x88.9mm/0.4mm NDY304M06A D-Y Plate, Middle, 6Hole 14.3x9.8 mm/0.4mm NDY304L06A D-Y Plate, Long, 6Hole 18.8x9.8mm/0.4mm NYP304M05A Y-Plate, Middle, 5Hole 20.1x9.8mm/0.4mm NXP304M04A X-Plate, Middle, 4Hole 11.0x11.0mm/0.4mm NSQ304M04A Square Plate, Middle, 4Hole 12.0x12.0mm/0.4mm NSQ304L04A Square Plate, Long, 4Hole 14.0x14.0mm/0.4mm NSQ304X04A Square Plate, Extra Long, 4Hole 16.0x16.0mm/0.4mm NRE304M04A Rectangular Plate, Middle, 4Hole 16.0x10.0mm/0.4mm NDS304M06A Double Square Plate, Middle, 6Hole 24.0x14.0mm/0.4mm NQD304M08A Matrix Plate, Middle, 8Hole 28.0x12.0mm/0.4mm NQD304L08A Matrix Plate, Long, 8Hole 34.0x14.0mm/0.4mm NBP304S06A Burr Hole Plate, Short, 6Hole 18.4mm/0.4mm NBP304M06A Burr Hole Plate, Middle, 6Hole 21.4mm/0.4mm NBP304L06A Burr Hole Plate, Long, 6Hole 23.4mm/0.4mm NBP304X06A Burr Hole Plate, Extra, 6Hole 30.4mm/0.4mm NBS304S05A Burr Hole Plate Slot, Short, 5Hole 18.4x14.7mm/0.4mm NBS304M05A Burr Hole Plate Slot, Middle, 5Hole 21.4x16.9mm/0.4mm NBS304L05A Burr Hole Plate Slot, Long, 5Hole 23.4x18.4mm/0.4mm NBS304X05A Burr Hole Plate Slot, Extra, 5Hole 30.4x24.3mm/0.4mm NBC304M06A Burr Hole Calvarium Plate, Middle, 6Hole 25.9 m/0.4mm NBC304L06A Burr Hole Calvarium Plate, Long, 6Hole 30.9 m/0.4mm NGP204S06A Gap Plate, Short, 6Hole 28.8x14.5mm/0.4mm NGP204M06A Gap Plate, Middle, 6Hole 38.8x15.3mm/0.4mm NGP204L06A Gap Plate, Long, 6Hole 48.8x16.2mm/0.4mm NTE204M00A Temporal Mesh Plate 42.2*25.1mm/0.4mm NME103S00 MESH PLATE 40.2*25.2mm/0.3mm NME103M00 MESH PLATE 40.2*50.2mm/0.3mm N3D206S00A 3D Mesh Plate 50*50mm/0.6mm N3D206M00A 3D Mesh Plate 100*100mm/0.6mm N3D206L00A 3D Mesh Plate 150*150mm/0.6mm N3D206X00A 3D Mesh Plate 200*200mm/0.6mm TSN-012 cod: N15A04 (Diam.: 1,5 mm; Long.: 4,0 mm) cant.: 100/disk NSP-002 cod: N15A04 (Diam.: 1,5 mm; Long.: 4,0 mm) cant.: 6/pouch TSN-013 cod: N15A03 (Diam.: 1,5 mm; Long.: 3,0 mm) cant.: 6/magazine TSN-014 cod: N15A05 (Diam.: 1,5 mm; Long.: 5,0 mm) cant.: 6/magazine TSN-017 cod: N15A04 (Diam.: 1,5 mm; Long.: 4,0 mm) cant.: 6/magazine NSP-001 cod: N15A03 (Diam.: 1,5 mm; Long.: 3,0 mm) cant.: 10/pouch NSP-003 cod: N15A05 (Diam.: 1,5 mm; Long.: 5,0 mm) cant.: 10/pouch NSP-004 cod: N18004 (Diam.: 1,8 mm; Long.: 4,0 mm) cant.: 10/pouch NSP-005 cod: N18006 (Diam.: 1,8 mm; Long.: 6,0 mm) cant.: 10/pouch TSN-015 cod: N18004 (Diam.: 1,8 mm; Long.: 4,0 mm) cant.: 10/magazine TSN-016 cod: N18006 (Diam.: 1,8 mm; Long.: 6,0 mm) cant.: 10/magazine • Optimus Instrument System Descripción: Sistema instrumental CMF no estéril Articulo: NDB-01 Drill Bit Ø 1.1 x 52.0 mm NDB-02 Drill Bit Ø1.1 x 52.0 mm (j-notch) LDS-01 Driver Shaft 75.0 mm LDS-02 Driver Shaft for Power Driver 57.0 mm IOC-033 Forceps 130mm IOC-040 plate cutter 110.0 mm IOC-017 Hand Driver (Big) 100mm IOC-018 Hand Driver (Small) 100mm IOC-041 Mesh cutter 190mm IOC-070 Plate bender 150 mm TPN-007 ALU Tray coated with PU (body + drawer + Lid) 217x157x37 TPN-005 ALU Tray oxidized (body + drawer + lid) • Sterile Neuro Plating System Descripción: Sistema de Placa Neurológica Estéril Articulo: NST304L02AS cod: NST304L02A cant.: 1 NST304X02AS cod: NST304X02A cant.: 1 NST304L04AS cod: NST304L04A cant.: 1 NST304X04AS cod: NST304X04A cant.: 1 NST304M05AS cod: NST304M05A cant.: 1 NST304M06AS cod: NST304M06A cant.: 1 NST304M10AS cod: NST304M10A cant.: 1 NDY304M06AS cod: NDY304M06A cant.: 1 NDY304L06AS cod: NDY304L06A cant.: 1 NYP304M05AS cod: NYP304M05A cant.: 1 NXP304M04AS cod: NXP304M04A cant.: 1 NSQ304M04AS cod: NSQ304M04A cant.: 1 NSQ304L04AS cod: NSQ304 L04A cant.: 1 NSQ304X04AS cod: NSQ304X04A cant.: 1 NRE304M04AS cod: NRE304M04A cant.: 1 NDS304M06AS cod: NDS304M06A cant.: 1 NQD304M08AS cod: NQD304M08A cant.: 1 NQD304L08AS cod: NQD304L08A cant.: 1 NBP304S06AS cod: NBP304S06A cant.: 1 NBP304M06AS cod: NBP304M06A cant.: 1 NBP304L06AS cod: NBP304L06A cant.: 1 NBP304X06AS cod: NBP304X06A cant.: 1 NBS304S05AS cod: NBS304S05A cant.: 1 NBS304M05AS cod: NBS304M05A cant.: 1 NBS304L05AS cod: NBS304L05A cant.: 1 NBS304X05AS cod: NBS304X05A cant.: 1 NBC304M06AS cod: NBC304M06A cant.: 1 NBC304L06AS cod: NBC304L06A cant.: 1 NGP204S06AS cod: NGP204S06A cant.: 1 NGP204M06AS cod: NGP204M06A cant.: 1 NGP204L06AS cod: NGP204L06A cant.: 1 NTE204M00AS cod: NTE204M00A cant.: 1 NME103S00s cod: NME103S00 cant.: 1 NME103M00S cod: NME103M00 cant.: 1 N3D206S00AS cod: N3D206S00A cant.: 1 N15A03S1 cod: N15A03 (Diam: 1,5 mm; Long.: 3,0 mm) cant.: 1 N15A03S2 cod: N15A03 (Diam: 1,5 mm; Long.: 3,0 mm) cant.: 2 N15A03S6 cod: N15A03 (Diam: 1,5 mm; Long.: 3,0 mm) cant.: 6 N15A04S1 cod: N15A04 (Diam.: 1,5 mm; Long.: 4,0 mm) cant.: 1 N15A04S2 cod: N15A04 (Diam.: 1,5 mm; Long.: 4,0 mm) cant.: 2 N15A04S6 cod: N15A04 (Diam.: 1,5 mm; Long.: 4,0 mm) cant.: 6 N15A05S1 cod: N15A05 (Diam.: 1,5 mm; Long.: 5,0 mm) cant.: 1 N15A05S2 cod: N15A05 (Diam.: 1,5 mm; Long.: 5,0 mm) cant.: 2 N15A05S6 cod: N15A05 (Diam.: 1,5 mm; Long.: 5,0 mm) cant.: 6 N18004S1 cod: N18004 (Diam.: 1,8 mm; Long.: 4,0 mm) cant.: 1 N18004S2 cod: N18004 (Diam.: 1,8 mm; Long.: 4,0 mm) cant.: 2 N18006S1 cod: N18006 (Diam.: 1,8 mm; Long.: 6,0 mm) cant.: 1 N18006S2 cod: N18006 (Diam.: 1,8 mm; Long.: 6,0 mm) cant.: 2 TCN-011 cod: N15A04 (Diam.: 1,5 mm; Long.: 4,0 mm) cant.: 6, cod: NST304X02A, cant.: 3 TCN-021 cod: N15A04 (Diam.: 1,5 mm; Long.: 4,0 mm) cant.: 6, cod: NST304L02A, cant.: 3 TCN-031 cod: N15A04 (Diam.: 1,5 mm; Long.: 4,0 mm) cant.: 10, cod: NST304X02A cant.: 2, cod: NBP304L06A cant.: 1 TCN-041 cod: N15A04 (Diam.: 1,5 mm; Long.: 4,0 mm) cant.: 6, cod: NBP304L06A cant.: 1 TCN-051 cod: N15A04 (Diam.: 1,5 mm; Long.: 4,0 mm) cant.: 5, cod: NBS304L05A cant.: 5 TCN-012 cod: N15A04 (Diam.: 1,5 mm; Long.: 4,0 mm) cant.: 5, cod: N15004 (Diam.: 1,5 mm; Long.: 4,0 mm) cant.: 5, cod: NST304X02A, cant.: 5 TCN-022 cod: N15A04 (Diam.: 1,5 mm; Long.: 4,0 mm) cant.: 5, cod: N20A04 (Diam.: 1,5 mm; Long.: 4,0 mm) cant.: 5, cod: NST304D02 , cant.: 5 TCN-061 cod: N15A04 (Diam.: 1,5 mm; Long.: 4,0 mm) cant.: 6, cod: NDY304L06A, cant.: 1 TCN-032 cod: N15A04 (Diam.: 1,5 mm; Long.: 4,0 mm) cant.: 2, cod: NST304X02A, cant.: 1 • Power hand driver.

Spanish:

• Optimus CMF System. Descripción: Sistema de cirugía maxilofacial y mandibular no estéril Articulo: NST304L02A Straight Plate, Long, 2Hole 3.4x12.4mm/0.4mm NST304X02A Straight Plate, Extra, 2Hole 3.4x15.4mm/0.4mm NST304L04A Straight Plate, Middle, 4Hole 3.4x21.4mm/0.4mm NST304X04A Straight Plate, Extra, 4Hole 3.4x24.4mm/0.4mm NST304M05A Straight Plate, Middle, 5Hole 3.4x21.4mm/0.4mm NST304M06A Straight Plate, Middle, 6Hole 3.4x25.9mm/0.4mm NST304M10A Straight Plate, Middle, 10Hole 3.4x43.9mm/0.4mm NST304M20A Straight Plate, Middle, 20Hole 3.4x88.9mm/0.4mm NDY304M06A D-Y Plate, Middle, 6Hole 14.3x9.8 mm/0.4mm NDY304L06A D-Y Plate, Long, 6Hole 18.8x9.8mm/0.4mm NYP304M05A Y-Plate, Middle, 5Hole 20.1x9.8mm/0.4mm NXP304M04A X-Plate, Middle, 4Hole 11.0x11.0mm/0.4mm NSQ304M04A Square Plate, Middle, 4Hole 12.0x12.0mm/0.4mm NSQ304L04A Square Plate, Long, 4Hole 14.0x14.0mm/0.4mm NSQ304X04A Square Plate, Extra Long, 4Hole 16.0x16.0mm/0.4mm NRE304M04A Rectangular Plate, Middle, 4Hole 16.0x10.0mm/0.4mm NDS304M06A Double Square Plate, Middle, 6Hole 24.0x14.0mm/0.4mm NQD304M08A Matrix Plate, Middle, 8Hole 28.0x12.0mm/0.4mm NQD304L08A Matrix Plate, Long, 8Hole 34.0x14.0mm/0.4mm NBP304S06A Burr Hole Plate, Short, 6Hole 18.4mm/0.4mm NBP304M06A Burr Hole Plate, Middle, 6Hole 21.4mm/0.4mm NBP304L06A Burr Hole Plate, Long, 6Hole 23.4mm/0.4mm NBP304X06A Burr Hole Plate, Extra, 6Hole 30.4mm/0.4mm NBS304S05A Burr Hole Plate Slot, Short, 5Hole 18.4x14.7mm/0.4mm NBS304M05A Burr Hole Plate Slot, Middle, 5Hole 21.4x16.9mm/0.4mm NBS304L05A Burr Hole Plate Slot, Long, 5Hole 23.4x18.4mm/0.4mm NBS304X05A Burr Hole Plate Slot, Extra, 5Hole 30.4x24.3mm/0.4mm NBC304M06A Burr Hole Calvarium Plate, Middle, 6Hole 25.9 m/0.4mm NBC304L06A Burr Hole Calvarium Plate, Long, 6Hole 30.9 m/0.4mm NGP204S06A Gap Plate, Short, 6Hole 28.8x14.5mm/0.4mm NGP204M06A Gap Plate, Middle, 6Hole 38.8x15.3mm/0.4mm NGP204L06A Gap Plate, Long, 6Hole 48.8x16.2mm/0.4mm NTE204M00A Temporal Mesh Plate 42.2*25.1mm/0.4mm NME103S00 MESH PLATE 40.2*25.2mm/0.3mm NME103M00 MESH PLATE 40.2*50.2mm/0.3mm N3D206S00A 3D Mesh Plate 50*50mm/0.6mm N3D206M00A 3D Mesh Plate 100*100mm/0.6mm N3D206L00A 3D Mesh Plate 150*150mm/0.6mm N3D206X00A 3D Mesh Plate 200*200mm/0.6mm TSN-012 cod: N15A04 (Diam.: 1,5 mm; Long.: 4,0 mm) cant.: 100/disk NSP-002 cod: N15A04 (Diam.: 1,5 mm; Long.: 4,0 mm) cant.: 6/pouch TSN-013 cod: N15A03 (Diam.: 1,5 mm; Long.: 3,0 mm) cant.: 6/magazine TSN-014 cod: N15A05 (Diam.: 1,5 mm; Long.: 5,0 mm) cant.: 6/magazine TSN-017 cod: N15A04 (Diam.: 1,5 mm; Long.: 4,0 mm) cant.: 6/magazine NSP-001 cod: N15A03 (Diam.: 1,5 mm; Long.: 3,0 mm) cant.: 10/pouch NSP-003 cod: N15A05 (Diam.: 1,5 mm; Long.: 5,0 mm) cant.: 10/pouch NSP-004 cod: N18004 (Diam.: 1,8 mm; Long.: 4,0 mm) cant.: 10/pouch NSP-005 cod: N18006 (Diam.: 1,8 mm; Long.: 6,0 mm) cant.: 10/pouch TSN-015 cod: N18004 (Diam.: 1,8 mm; Long.: 4,0 mm) cant.: 10/magazine TSN-016 cod: N18006 (Diam.: 1,8 mm; Long.: 6,0 mm) cant.: 10/magazine • Optimus Instrument System Descripción: Sistema instrumental CMF no estéril Articulo: NDB-01 Drill Bit Ø 1.1 x 52.0 mm NDB-02 Drill Bit Ø1.1 x 52.0 mm (j-notch) LDS-01 Driver Shaft 75.0 mm LDS-02 Driver Shaft for Power Driver 57.0 mm IOC-033 Forceps 130mm IOC-040 plate cutter 110.0 mm IOC-017 Hand Driver (Big) 100mm IOC-018 Hand Driver (Small) 100mm IOC-041 Mesh cutter 190mm IOC-070 Plate bender 150 mm TPN-007 ALU Tray coated with PU (body + drawer + Lid) 217x157x37 TPN-005 ALU Tray oxidized (body + drawer + lid) • Sterile Neuro Plating System Descripción: Sistema de Placa Neurológica Estéril Articulo: NST304L02AS cod: NST304L02A cant.: 1 NST304X02AS cod: NST304X02A cant.: 1 NST304L04AS cod: NST304L04A cant.: 1 NST304X04AS cod: NST304X04A cant.: 1 NST304M05AS cod: NST304M05A cant.: 1 NST304M06AS cod: NST304M06A cant.: 1 NST304M10AS cod: NST304M10A cant.: 1 NDY304M06AS cod: NDY304M06A cant.: 1 NDY304L06AS cod: NDY304L06A cant.: 1 NYP304M05AS cod: NYP304M05A cant.: 1 NXP304M04AS cod: NXP304M04A cant.: 1 NSQ304M04AS cod: NSQ304M04A cant.: 1 NSQ304L04AS cod: NSQ304 L04A cant.: 1 NSQ304X04AS cod: NSQ304X04A cant.: 1 NRE304M04AS cod: NRE304M04A cant.: 1 NDS304M06AS cod: NDS304M06A cant.: 1 NQD304M08AS cod: NQD304M08A cant.: 1 NQD304L08AS cod: NQD304L08A cant.: 1 NBP304S06AS cod: NBP304S06A cant.: 1 NBP304M06AS cod: NBP304M06A cant.: 1 NBP304L06AS cod: NBP304L06A cant.: 1 NBP304X06AS cod: NBP304X06A cant.: 1 NBS304S05AS cod: NBS304S05A cant.: 1 NBS304M05AS cod: NBS304M05A cant.: 1 NBS304L05AS cod: NBS304L05A cant.: 1 NBS304X05AS cod: NBS304X05A cant.: 1 NBC304M06AS cod: NBC304M06A cant.: 1 NBC304L06AS cod: NBC304L06A cant.: 1 NGP204S06AS cod: NGP204S06A cant.: 1 NGP204M06AS cod: NGP204M06A cant.: 1 NGP204L06AS cod: NGP204L06A cant.: 1 NTE204M00AS cod: NTE204M00A cant.: 1 NME103S00s cod: NME103S00 cant.: 1 NME103M00S cod: NME103M00 cant.: 1 N3D206S00AS cod: N3D206S00A cant.: 1 N15A03S1 cod: N15A03 (Diam: 1,5 mm; Long.: 3,0 mm) cant.: 1 N15A03S2 cod: N15A03 (Diam: 1,5 mm; Long.: 3,0 mm) cant.: 2 N15A03S6 cod: N15A03 (Diam: 1,5 mm; Long.: 3,0 mm) cant.: 6 N15A04S1 cod: N15A04 (Diam.: 1,5 mm; Long.: 4,0 mm) cant.: 1 N15A04S2 cod: N15A04 (Diam.: 1,5 mm; Long.: 4,0 mm) cant.: 2 N15A04S6 cod: N15A04 (Diam.: 1,5 mm; Long.: 4,0 mm) cant.: 6 N15A05S1 cod: N15A05 (Diam.: 1,5 mm; Long.: 5,0 mm) cant.: 1 N15A05S2 cod: N15A05 (Diam.: 1,5 mm; Long.: 5,0 mm) cant.: 2 N15A05S6 cod: N15A05 (Diam.: 1,5 mm; Long.: 5,0 mm) cant.: 6 N18004S1 cod: N18004 (Diam.: 1,8 mm; Long.: 4,0 mm) cant.: 1 N18004S2 cod: N18004 (Diam.: 1,8 mm; Long.: 4,0 mm) cant.: 2 N18006S1 cod: N18006 (Diam.: 1,8 mm; Long.: 6,0 mm) cant.: 1 N18006S2 cod: N18006 (Diam.: 1,8 mm; Long.: 6,0 mm) cant.: 2 TCN-011 cod: N15A04 (Diam.: 1,5 mm; Long.: 4,0 mm) cant.: 6, cod: NST304X02A, cant.: 3 TCN-021 cod: N15A04 (Diam.: 1,5 mm; Long.: 4,0 mm) cant.: 6, cod: NST304L02A, cant.: 3 TCN-031 cod: N15A04 (Diam.: 1,5 mm; Long.: 4,0 mm) cant.: 10, cod: NST304X02A cant.: 2, cod: NBP304L06A cant.: 1 TCN-041 cod: N15A04 (Diam.: 1,5 mm; Long.: 4,0 mm) cant.: 6, cod: NBP304L06A cant.: 1 TCN-051 cod: N15A04 (Diam.: 1,5 mm; Long.: 4,0 mm) cant.: 5, cod: NBS304L05A cant.: 5 TCN-012 cod: N15A04 (Diam.: 1,5 mm; Long.: 4,0 mm) cant.: 5, cod: N15004 (Diam.: 1,5 mm; Long.: 4,0 mm) cant.: 5, cod: NST304X02A, cant.: 5 TCN-022 cod: N15A04 (Diam.: 1,5 mm; Long.: 4,0 mm) cant.: 5, cod: N20A04 (Diam.: 1,5 mm; Long.: 4,0 mm) cant.: 5, cod: NST304D02 , cant.: 5 TCN-061 cod: N15A04 (Diam.: 1,5 mm; Long.: 4,0 mm) cant.: 6, cod: NDY304L06A, cant.: 1 TCN-032 cod: N15A04 (Diam.: 1,5 mm; Long.: 4,0 mm) cant.: 2, cod: NST304X02A, cant.: 1 • Power hand driver.

Device Classification
Registration Type
Registration Class III-IV
Registro Clase III-IV
Product Code
669-382
Brand Name
Osteonic
Product Name
Implant for fixation of cranial fractures.
Implante de fijación de fracturas craneales.
Registration Information
Registration Date
May 13, 2024
Database ID
cmhaytks401wzekuzcnw6ugjh
Documents
Authorized Representative