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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Arthroscope
510(k) Number K233800
Device Name Vertos mild Device Kit (MDK-0002)
Applicant
Vertos Medical, Inc.
95 Enterprise Unit 325
Aliso Viejo,  CA  92656
Applicant Contact Russ Alexander
Correspondent
Vertos Medical, Inc.
95 Enterprise Unit 325
Aliso Viejo,  CA  92656
Correspondent Contact Lisa Maloney
Regulation Number888.1100
Classification Product Code
HRX  
Subsequent Product Code
HAE  
Date Received11/29/2023
Decision Date 05/06/2024
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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