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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 K061262
Device Name LIGAFIX INTERFERENCE SCREW
Applicant
Sciences For Bio Materials
Zi Du Monge
Lourdes,  FR F 65100
Applicant Contact DENIS CLEMENT
Correspondent
Sciences For Bio Materials
Zi Du Monge
Lourdes,  FR F 65100
Correspondent Contact DENIS CLEMENT
Regulation Number888.3040
Classification Product Code
HWC  
Date Received05/05/2006
Decision Date 07/05/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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