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

Instrument, Biopsy

Avitus Orthopaedics, Inc

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

Pre-market Notification Details

Device IDK170539
510k NumberK170539
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
ClassificationInstrument, Biopsy
Applicant Avitus Orthopaedics, Inc 400 Farmington Ave Suite R2826, CB889 Farmington,  CT  06032
ContactMaxim Budyansky
CorrespondentMaxim Budyansky
Avitus Orthopaedics, Inc 400 Farmington Ave Suite R2826, CB889 Farmington,  CT  06032
Product CodeKNW  
CFR Regulation Number876.1075 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-02-23
Decision Date2017-03-20
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00857373006050 K170539 000
00857373006029 K170539 000
00857373006074 K170539 000

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