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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 K222512
Device Name Integrity-SI Fusion System
Applicant
OsteoCentric Technologies
75 W. 300 N.
Suite 150
Logan,  UT  84321
Applicant Contact Todd Evans
Correspondent
Telos Partners, LLC
2850 Frontier Dr.
Warsaw,  IN  46582
Correspondent Contact Ken Riordan
Regulation Number888.3040
Classification Product Code
OUR  
Date Received08/19/2022
Decision Date 09/12/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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