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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 K122737
Device Name GEMINUS FOSSA SPECIFIC PLATE SYSTEM
Applicant
SKELETAL DYNAMICS, LLC
8905 SW 87 AVENUE, SUITE 201
MIAMI,  FL  33176
Applicant Contact ANA M ESCAGEDO
Correspondent
SKELETAL DYNAMICS, LLC
8905 SW 87 AVENUE, SUITE 201
MIAMI,  FL  33176
Correspondent Contact ANA M ESCAGEDO
Regulation Number888.3030
Classification Product Code
HRS  
Date Received09/06/2012
Decision Date 10/03/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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