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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cerclage, Fixation
510(k) Number K001254
Device Name ORTHOMATRIX, INC. CERCLAGE SYSTEM
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 Number888.3010
Classification Product Code
JDQ  
Date Received04/19/2000
Decision Date 12/13/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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