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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Rod, Fixation, Intramedullary And Accessories
510(k) Number K992856
Device Name MAGELLAN HUMERAL INTRAMEDULLARY NAIL
Applicant
Orthomatrix, Inc.
711 Chaney Cove
Collierville,  TN  38017
Applicant Contact BEN SHAPPLEY
Correspondent
Orthomatrix, Inc.
711 Chaney Cove
Collierville,  TN  38017
Correspondent Contact BEN SHAPPLEY
Regulation Number888.3020
Classification Product Code
HSB  
Date Received08/24/1999
Decision Date 03/10/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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