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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 K200108
Device Name GEO 1st MTP Joint Arthrodesis Plating System
Applicant
Gramercy Extremity Orthopedics, LLC
1239 N Glenville Dr
Richardson,  TX  75081
Applicant Contact Michael P. Simpson
Correspondent
Gramercy Extremity Orthopedics, LLC
1239 N Glenville Dr
Richardson,  TX  75081
Correspondent Contact Michael P. Simpson
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received01/17/2020
Decision Date 03/26/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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