SILVERBACK Gorilla Plating System

Screw, Fixation, Bone

Paragon 28, Inc.

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

Pre-market Notification Details

Device IDK182148
510k NumberK182148
Device Name:SILVERBACK Gorilla Plating System
ClassificationScrew, Fixation, Bone
Applicant Paragon 28, Inc. 4B Inverness Ct. E, STE 280 Engelwood,  CO  80112
ContactEric Lintula
CorrespondentEric Lintula
Paragon 28, Inc. 4B Inverness Ct. E, STE 280 Englewood,  CO  80112
Product CodeHWC  
Subsequent Product CodeHRS
Subsequent Product CodeHTN
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-08-08
Decision Date2018-09-07
Summary:summary

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