SurGenTec, LLC

18 devices* 23 registrations
✕ UK (MHRA) ✕ EU (EUDAMED) ✕ Canada (Health Canada)
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Devices

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Device Name US UK CA AU EU
3D GraftRasp System Registered with US (FDA) Not registered with UK (MHRA) Not registered with Canada (Health Canada) AU (TGA): manufacturer registered, device not confirmed Not registered with EU (EUDAMED)
ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit) Registered with US (FDA) Not registered with UK (MHRA) Not registered with Canada (Health Canada) AU (TGA): manufacturer registered, device not confirmed Not registered with EU (EUDAMED)
ALARA Neuro Access Kit Registered with US (FDA) Not registered with UK (MHRA) Not registered with Canada (Health Canada) AU (TGA): manufacturer registered, device not confirmed Not registered with EU (EUDAMED)
Graftgun Universal Graft Delivery System Registered with US (FDA) Not registered with UK (MHRA) Not registered with Canada (Health Canada) Registered with AU (TGA) Not registered with EU (EUDAMED)
GraftGun Universal Graft Delivery System (GDS) Registered with US (FDA) Not registered with UK (MHRA) Not registered with Canada (Health Canada) AU (TGA): manufacturer registered, device not confirmed Not registered with EU (EUDAMED)
Ion 3D Registered with US (FDA) Not registered with UK (MHRA) Not registered with Canada (Health Canada) AU (TGA): manufacturer registered, device not confirmed Not registered with EU (EUDAMED)
Ion-C Registered with US (FDA) Not registered with UK (MHRA) Not registered with Canada (Health Canada) AU (TGA): manufacturer registered, device not confirmed Not registered with EU (EUDAMED)
Ion-C Navigation Instruments Registered with US (FDA) Not registered with UK (MHRA) Not registered with Canada (Health Canada) AU (TGA): manufacturer registered, device not confirmed Not registered with EU (EUDAMED)
Ion Facet Screw System Registered with US (FDA) Not registered with UK (MHRA) Not registered with Canada (Health Canada) AU (TGA): manufacturer registered, device not confirmed Not registered with EU (EUDAMED)
Ion-L Registered with US (FDA) Not registered with UK (MHRA) Not registered with Canada (Health Canada) AU (TGA): manufacturer registered, device not confirmed Not registered with EU (EUDAMED)
OsteoFlo HydroFiber Registered with US (FDA) Not registered with UK (MHRA) Not registered with Canada (Health Canada) Registered with AU (TGA) Not registered with EU (EUDAMED)
OsteoFlo® HydroPutty™ Registered with US (FDA) Not registered with UK (MHRA) Not registered with Canada (Health Canada) Registered with AU (TGA) Not registered with EU (EUDAMED)
OsteoFlo NanoPutty-Quadphasic Synthetic Bone Graft Registered with US (FDA) Not registered with UK (MHRA) Not registered with Canada (Health Canada) AU (TGA): manufacturer registered, device not confirmed Not registered with EU (EUDAMED)
TiLink-L Joint Fusion System Registered with US (FDA) Not registered with UK (MHRA) Not registered with Canada (Health Canada) AU (TGA): manufacturer registered, device not confirmed Not registered with EU (EUDAMED)
TiLink-L Navigation Instruments Registered with US (FDA) Not registered with UK (MHRA) Not registered with Canada (Health Canada) AU (TGA): manufacturer registered, device not confirmed Not registered with EU (EUDAMED)
TiLink-L SI Joint Fusion System Registered with US (FDA) Not registered with UK (MHRA) Not registered with Canada (Health Canada) AU (TGA): manufacturer registered, device not confirmed Not registered with EU (EUDAMED)
TiLink-P Joint Fusion System Registered with US (FDA) Not registered with UK (MHRA) Not registered with Canada (Health Canada) AU (TGA): manufacturer registered, device not confirmed Not registered with EU (EUDAMED)
TiLink-P SI Joint Fusion System Registered with US (FDA) Not registered with UK (MHRA) Not registered with Canada (Health Canada) AU (TGA): manufacturer registered, device not confirmed Not registered with EU (EUDAMED)

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