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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 K222448
Device Name UNITY Sacroiliac Joint Fixation System
Applicant
Dio Medical Corporation
2100 Campus Ln.
Suite 100
East Norriton,  PA  19403
Applicant Contact Milan George
Correspondent
Dio Medical Corporation
2100 Campus Ln.
Suite 100
East Norriton,  PA  19403
Correspondent Contact Milan George
Regulation Number888.3040
Classification Product Code
OUR  
Date Received08/15/2022
Decision Date 10/13/2022
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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