Avanti Orthopaedics Ulnar Shortening System

Plate, Fixation, Bone

Avanti Orthopaedics, Inc.

The following data is part of a premarket notification filed by Avanti Orthopaedics, Inc. with the FDA for Avanti Orthopaedics Ulnar Shortening System.

Pre-market Notification Details

Device IDK211592
510k NumberK211592
Device Name:Avanti Orthopaedics Ulnar Shortening System
ClassificationPlate, Fixation, Bone
Applicant Avanti Orthopaedics, Inc. 4606 Simon Road Wilmington,  DE  19803
ContactJ. Doug Patterson
CorrespondentLinda Braddon
Secure BioMed Evaluations 7828 Hickory Flat Highway Suite 120 Woodstock,  GA  30188
Product CodeHRS  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-05-24
Decision Date2021-07-16

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