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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 K113388
Device Name CITIEFFE-TITANIUM CANNULATED SCREW
Applicant
Citieffe
110 E. Granada Blvd. Suite 209
Ormond Beach,  FL  32176
Applicant Contact Claude Berthoin
Correspondent
Citieffe
110 E. Granada Blvd. Suite 209
Ormond Beach,  FL  32176
Correspondent Contact Claude Berthoin
Regulation Number888.3040
Classification Product Code
HWC  
Date Received11/16/2011
Decision Date 06/05/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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