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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name screw, fixation, bone
510(k) Number K070507
Device Name MODIFICATION TO: LIGAFIX INTERFERENCE SCREW
Applicant
SCIENCE FOR BIOMATERIALS
ZI DU MONGE
LOURDES,  FR 65100
Applicant Contact DENIS CLEMENT
Correspondent
SCIENCE FOR BIOMATERIALS
ZI DU MONGE
LOURDES,  FR 65100
Correspondent Contact DENIS CLEMENT
Regulation Number888.3040
Classification Product Code
HWC  
Date Received02/21/2007
Decision Date 03/29/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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