Biofusion Medical

FDA Filings

This page includes the latest FDA filings for Biofusion Medical. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3015422154
FEI Number3015422154
NameBIOFUSION MEDICAL
Owner & OperatorBiofusion Medical
Contact Address2101 E St Elmo Rd Bldg 1, Ste 100, PMB-1, Office 231
Austin TX 78744 US
Official Correspondent
  • Rylan Reed
  • 1-866-4890602-x
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address2101 E St Elmo Rd Bldg 1, Ste 100, PMB-1, Office 231
Austin, TX 78744 US
Establishment TypeDevelop Specifications But Do Not Manufacture At This Facility



FDA Filings

Device
Company
DeviceDate
Biofusion Medical
SI-Restore Sacroiliac Joint Fixation System2020-04-17
BIOFUSION MEDICAL
SI-Restore2019-03-07
Biofusion Medical
SI-Restore® Sacroiliac Joint Fixation System2019-01-25

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