G3¿ Active Plate® Large Fragment System

Plate, Fixation, Bone

GENESIS FRACTURE CARE, INC.

The following data is part of a premarket notification filed by Genesis Fracture Care, Inc. with the FDA for G3¿ Active Plate® Large Fragment System.

Pre-market Notification Details

Device IDK152242
510k NumberK152242
Device Name:G3¿ Active Plate® Large Fragment System
ClassificationPlate, Fixation, Bone
Applicant GENESIS FRACTURE CARE, INC. 13568 SE 97TH AVE., SUITE 202 Clackamas,  OR  97105
ContactMichael Bottlang
CorrespondentChristine Scifert
MEMPHIS REGULATORY CONSULTING, LLC 3416 ROXEE RUN Bartlett,  TN  38133
Product CodeHRS  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-08-10
Decision Date2015-11-24
Summary:summary

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.