FDA.reportPublic FDA data

BIOFUSION MEDICAL

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30154221543015422154BIOFUSION MEDICAL1N2026-01-014020 S Industrial Drive Ste 135 Austin TX US 78744

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2279351936211086K200868SI-Restore Sacroiliac Joint Fixation SystemOUR2020-04-17
2279352055208272K182919SI-Restore® Sacroiliac Joint Fixation SystemOUR2019-01-25

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
OUR22020-04-17

PMN#