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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Spinous Process Plate
510(k) Number K223790
Device Name Huvex Interspinous Fusion System
Applicant
Dio Medical Corp.
2100 Campus Lane
Suite 100
East Norriton,  PA  19403
Applicant Contact Milan George
Correspondent
Dio Medical Corp.
2100 Campus Lane
Suite 100
East Norriton,  PA  19403
Correspondent Contact Milan George
Regulation Number888.3050
Classification Product Code
PEK  
Date Received12/19/2022
Decision Date 03/09/2023
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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