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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name instrument, biopsy
510(k) Number K210631
Device Name Avitus(r) Bone Harvester
Avitus Orthopaedics, Inc.
6 Amstrong Rd, Suite 107
shelton,  CT  06484
Applicant Contact maxim budyansky
Keystone Regulatory Services, LLC
342 E. Main Street
leola,  PA  17540
Correspondent Contact william mclain
Regulation Number876.1075
Classification Product Code
Date Received03/03/2021
Decision Date 03/31/2021
Decision substantially equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Orthopedic
summary summary
Type Special
Reviewed by Third Party No
Combination Product No