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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 K150875
Device Name iFuse Implant System
Applicant
SI-BONE, Inc.
3055 Olin Ave., Suite 2200
San Jose,  CA  95128
Applicant Contact Roxanne Dubois
Correspondent
SI-BONE, Inc.
3055 Olin Ave., Suite 2200
San Jose,  CA  95128
Correspondent Contact Roxanne Dubois
Regulation Number888.3040
Classification Product Code
OUR  
Date Received04/01/2015
Decision Date 07/22/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Clinical Trials NCT01640353
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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