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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plate, Fixation, Bone
510(k) Number K210534
Device Name GEO FirstFUSE 1st MTP Joint Arthrodesis Plating System
Applicant
Gramercy Extremity Orthopedics, LLC
1239 N. Glenville Dr.
Richardson,  TX  75081
Applicant Contact Michael P. Simpson
Correspondent
Novus Management Group, LLC
4480 Lake Forest Dr., Suite 412
Blue Ash,  OH  45242
Correspondent Contact Tamala J. Wampler
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received02/24/2021
Decision Date 03/26/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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