Baby Gorilla/Gorilla Plating System

Plate, Fixation, Bone

Paragon 28, Inc.

The following data is part of a premarket notification filed by Paragon 28, Inc. with the FDA for Baby Gorilla/gorilla Plating System.

Pre-market Notification Details

Device IDK221465
510k NumberK221465
Device Name:Baby Gorilla/Gorilla Plating System
ClassificationPlate, Fixation, Bone
Applicant Paragon 28, Inc. 14445 Grasslands Dr. Englewood,  CO  80112
ContactHaylie Hertz
CorrespondentHaylie Hertz
Paragon 28, Inc. 14445 Grasslands Dr. Englewood,  CO  80112
Product CodeHRS  
Subsequent Product CodeHTN
Subsequent Product CodeHWC
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-05-19
Decision Date2022-06-17

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