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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Staple, Fixation, Bone
510(k) Number K123926
Device Name METASURG NITINOL STAPLE IMPLANT
Applicant
Metasurg
Suite 100
Houston,  TX  77084
Applicant Contact JOSHUA SCOTT
Correspondent
Metasurg
Suite 100
Houston,  TX  77084
Correspondent Contact JOSHUA SCOTT
Regulation Number888.3030
Classification Product Code
JDR  
Date Received12/20/2012
Decision Date 05/03/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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