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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 K170539
Device Name Avitus Bone Harvester with Filter Insert - 5mm, Avitus Bone Harvester - 5mm, Avitus Bone Harvester with Filter Insert - 8mm, Avitus Filter Insert - 8mm, Avitus Filter Insert - 5mm
Applicant
Avitus Orthopaedics, Inc.
400 Farmington Ave. Suite R2826, Cb889
Farmington,  CT  06032
Applicant Contact Maxim Budyansky
Correspondent
Avitus Orthopaedics, Inc.
400 Farmington Ave. Suite R2826, Cb889
Farmington,  CT  06032
Correspondent Contact Maxim Budyansky
Regulation Number876.1075
Classification Product Code
KNW  
Date Received02/23/2017
Decision Date 03/20/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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