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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 K242431
Device Name Omnia Medical PsiF DNA™ System
Applicant
Omnia Medical, LLC
6 Canyon Rd., Suite 300
Morgantown,,  WV  26508
Applicant Contact Troy Schifano
Correspondent
Sagemar Medical, LLC
30628 Detroit Rd., #254
Westlake,  OH  44145
Correspondent Contact Jennifer Palinchik
Regulation Number888.3040
Classification Product Code
OUR  
Date Received08/16/2024
Decision Date 06/06/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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