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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name fastener, fixation, biodegradable, soft tissue
510(k) Number K122228
Device Name LIGAFIX INTERFERENCE SCREW
Applicant
SBM SCIENCES FOR BIO MATERIALS
ZI DU MONGE
LOURDES,  FR 65100
Applicant Contact DENIS CLEMENT
Correspondent
SBM SCIENCES FOR BIO MATERIALS
ZI DU MONGE
LOURDES,  FR 65100
Correspondent Contact DENIS CLEMENT
Regulation Number888.3030
Classification Product Code
MAI  
Date Received07/26/2012
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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