Avanti Orthopaedics 2.2mm And 2.7mm Cannulated Screws, Avanti Orthopaedics 3.2mm And 4.0mm Cannulated Screws

Screw, 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 2.2mm And 2.7mm Cannulated Screws, Avanti Orthopaedics 3.2mm And 4.0mm Cannulated Screws.

Pre-market Notification Details

Device IDK222967
510k NumberK222967
Device Name:Avanti Orthopaedics 2.2mm And 2.7mm Cannulated Screws, Avanti Orthopaedics 3.2mm And 4.0mm Cannulated Screws
ClassificationScrew, Fixation, Bone
Applicant Avanti Orthopaedics, Inc. 1814 Gilpin Avenue Wilmington,  DE  19806
ContactJ. Doug Patterson
CorrespondentLinda Braddon
Secure BioMed Evaluations 7828 Hickory Flat Highway Suite 120 Woodstock,  GA  30188
Product CodeHWC  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-09-27
Decision Date2022-11-23

NIH GUDID Devices

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