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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Piston
510(k) Number K230492
Device Name Avitus® Precision Autograft Delivery System
Applicant
Avitus Orthopaedics, Inc.
6 Armstrong Rd., Suite 107
Shelton,  CT  06484
Applicant Contact Maxim Budyansky
Correspondent
Keystone Regulatory Services, LLC
324 E. Main St.
Leola,  PA  17540
Correspondent Contact Robert McLain
Regulation Number880.5860
Classification Product Code
FMF  
Date Received02/23/2023
Decision Date 06/26/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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