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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name sacroiliac joint fixation
510(k) Number K182919
Device Name SI-Restore® Sacroiliac Joint Fixation System
Applicant
Biofusion Medical
2503 Cedarview Drive
Austin,  TX  78704
Applicant Contact Rylan Reed
Correspondent
SurgOp Support
7512 Lancaster Gate
Frisco,  TX  75035
Correspondent Contact Daniel Lanois
Regulation Number888.3040
Classification Product Code
OUR  
Date Received10/19/2018
Decision Date 01/25/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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