GEO FirstFUSE 1st MTP Joint Arthrodesis Plating System

Plate, Fixation, Bone

Gramercy Extremity Orthopedics, LLC

The following data is part of a premarket notification filed by Gramercy Extremity Orthopedics, Llc with the FDA for Geo Firstfuse 1st Mtp Joint Arthrodesis Plating System.

Pre-market Notification Details

Device IDK210534
510k NumberK210534
Device Name:GEO FirstFUSE 1st MTP Joint Arthrodesis Plating System
ClassificationPlate, Fixation, Bone
Applicant Gramercy Extremity Orthopedics, LLC 1239 N Glenville Dr Richardson,  TX  75081
ContactMichael P. Simpson
CorrespondentTamala J. Wampler
Novus Management Group, LLC 4480 Lake Forest Drive, Ste. 412 Blue Ash,  OH  45242
Product CodeHRS  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-02-24
Decision Date2021-03-26

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