Avitus(r) Bone Harvester

Instrument, Biopsy

Avitus Orthopaedics, Inc.

The following data is part of a premarket notification filed by Avitus Orthopaedics, Inc. with the FDA for Avitus(r) Bone Harvester.

Pre-market Notification Details

Device IDK210631
510k NumberK210631
Device Name:Avitus(r) Bone Harvester
ClassificationInstrument, Biopsy
Applicant Avitus Orthopaedics, Inc. 6 Amstrong Rd, Suite 107 Shelton,  CT  06484
ContactMaxim Budyansky
CorrespondentWilliam Mclain
Keystone Regulatory Services, LLC 342 E. Main Street Leola,  PA  17540
Product CodeKNW  
CFR Regulation Number876.1075 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-03-03
Decision Date2021-03-31

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