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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 K071952
Device Name GRAFTLOCK SCREW, ST SCREW
Applicant
Biocomposites, Ltd.
Keele Science Park
Keele,  GB ST5 5NL
Applicant Contact SIMON FITZER
Correspondent
Biocomposites, Ltd.
Keele Science Park
Keele,  GB ST5 5NL
Correspondent Contact SIMON FITZER
Regulation Number888.3040
Classification Product Code
HWC  
Subsequent Product Codes
JDR   MAI  
Date Received07/16/2007
Decision Date 08/14/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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