BIOFUSION MEDICAL

FDA Device Registration & Listing · Austin, TX, US · Registration 3015422154

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3015422154
FEI Number
3015422154
Entity Name
BIOFUSION MEDICAL
City/State/Country
Austin, TX, US
Establishment Address
4020 S Industrial Drive, Ste 135, Austin, TX 78744, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Biofusion Medical (Owner Number: 10059912)
Owner / Operator Contact Address
4020 S Industrial Drive Suite 135, Austin, TX 78744, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K182919
PMA Number
N/A

All Registered Proprietary Names

SI-Restore

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
OUR Sacroiliac Joint Fixation Orthopedic Class 2 888.3040 2019-03-07

Official Correspondent

Rylan Reed

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Biofusion Medical
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K213667 SI-BONE, Inc. iFuse-TORQ® Implant System 2022-06-10

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3004499989 LIFE SPINE Huntley, IL, US
3010143171 AR FABRICATING Georgetown, TX, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015422154. Last updated year: 2026. Please use registration number 3015422154 when referencing this establishment in official correspondence.
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