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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Appliance, Fixation, Spinal Intervertebral Body
510(k) Number K222572
Device Name FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate System, and BALTEUM™ & BALTEUM-ONE™ Lumbar Plate 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 Number888.3060
Classification Product Code
KWQ  
Date Received08/25/2022
Decision Date 10/18/2022
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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