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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Facet Screw Spinal Device
510(k) Number K222515
Device Name FaSet 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
Classification Product Code
MRW  
Date Received08/19/2022
Decision Date 10/05/2022
Decision Substantially Equivalent (SESE)
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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