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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 K021351
Device Name BIOSTEON CROSS PIN
Applicant
BIOCOMPOSITES LTD.
ETRUSCAN ST., ETRURIA
STOKE ON TRENT,  GB ST1 5PQ
Applicant Contact J. STEPHEN BRATT
Correspondent
BIOCOMPOSITES LTD.
ETRUSCAN ST., ETRURIA
STOKE ON TRENT,  GB ST1 5PQ
Correspondent Contact J. STEPHEN BRATT
Regulation Number888.3040
Classification Product Code
HWC  
Date Received04/29/2002
Decision Date 10/17/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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