GEO Bone Screw System

Screw, 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 Bone Screw System.

Pre-market Notification Details

Device IDK202817
510k NumberK202817
Device Name:GEO Bone Screw System
ClassificationScrew, Fixation, Bone
Applicant Gramercy Extremity Orthopedics, LLC 1239 N. Glenville Dr. Richardson,  TX  75081
ContactMichael Simpson
CorrespondentMichael Simpson
Gramercy Extremity Orthopedics, LLC 1239 N. Glenville Dr. Richardson,  TX  75081
Product CodeHWC  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-09-24
Decision Date2020-10-22

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