Fiagon Navigation System

Land: Singapore

Taal: Engels

Bron: HSA (Health Sciences Authority)

Beschikbaar vanaf:

SMITH & NEPHEW PTE. LIMITED

klasse:

Class C medical device

Geproduceerd door:

Fiagon GmbH

Therapeutisch gebied:

General & Plastic Surgery

therapeutische indicaties:

The Fiagon Navigation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The Fiagon Navigation System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the skull, a long bone, or vertebra, can be identified relative to a CT or MR based model of the anatomy. Example procedures include, but are not limited to: Cranial Procedures: Cranial biopsies, Tumor resections, Craniotomies/Craniectomies, Skull base procedures, Thalamotomies/ Pallidotomies. Spinal Procedures; Spinal implant procedures, such as pedicle screw placement. ENT Procedures; Transphenoidal procedures, Intranasal procedures. Sinus procedures, such as Maxillary antrostomies, Ethmoidectomies, Sphenoidotomies/Sphenoid explorations,Turbinate resections, and Frontal sinusotomies.

Product samenvatting:

Models: Fiagon Navigation Unit - E 01 0013, Navigation headrest Flat - E 01 1001, Navigation headrest Maquet - E 01 1002, Navigation headrest Universal - E 01 1003, Navigation headrest Trumpf - E 01 1009, Navigation Headrest Brumaba - E 01 1006, Navigation headrest Horse shoe - E 01 1005, FlexPointer - E 01 2002, RegistrationPointer - E 01 2003, FlexPointer 1.5 - E 01 2004, PointerTube Straight - E 01 2101, PointerTube Keat - E 01 2107, PointerTube Stammberger - E 01 2102, PointerTube Sinus Frontalis - E 01 2103, FlexTube 3 mm - E 01 2104, FlexTube 4 mm - E 01 2106, FinePointer - E 01 2300, Curette Straight - E 01 2301, Curette Frontal - E 01 2302, PointerShell 4 mm - E 01 2900, PointerShell 5 mm - E 01 2901, PointerShell 3 mm - E 01 2902, PointerShell Universal - E 01 2904, PointerShell „open“ - E 01 2903, AwlPointer 3 - N 01 2023, AwlPointer 4 - N 01 2022, Spine Pointer - N 01 2021, CenterPointer - N 01 2020, VenteraPointer - E 01 2910, GuideWire - E 01 2911, ShuntPointer - N 01 2060, Biopsy Pointer 190 - N 01 2050, Biopsy Pointer 250 - N 01 2051, Localizer Headband - E 01 2200, Localizer Bone Screw - E 01 2201, Localizer Adhesive pad - E 01 2202, Localizer Pin - N 01 2213, Localizer Spine - N 01 2212, Headband - E 00 3000, Adhesive pad - E 00 3001, Navigation Frame - N 01 1010, Navigation Table Pad - N 01 1011, Automatic Registration Tracey - E 01 0105, Sterile Drape for Ipad - E 00 3004, Sterile Drape for Fiagon Tracey Instrument - E 00 3005, NeuroGate Trocar 14G - N 01 2221, NeuroGate Set 14G - N 01 2220, Mapper Pin - N 01 2703, Mapper Cage - N 01 2702, Navigation Sensor Skull clamp - N 01 1004 DR, Skull clamp for navigation - N 01 1904 DR, Mapper Frame - A 01 2704, Adapters for Maquet - E 01 1913, Adapters for Steris - E 01 1914, Adapters for Eschmann - E 01 1915, Adapters for siderail - E 01 1916, Adapters for Mizuho/Skytron - E 01 1917, Adapters for berchtold - E 01 1918, Extension Cable Instrument - A 00 1200, Extension cable localizer - A 00 1201, Double instrument support - A 01 1203, GuideWire 0.6 - E 01 2913, Fiagon Navigation Unit - E 01 1103

Autorisatie datum:

2020-10-08