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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 K081755
Device Name FUSION MEDICAL STI
Applicant
John Riccio
1663 S. Main St.
Waterbury,  CT  06706
Applicant Contact JOHN RICCIO
Correspondent
John Riccio
1663 S. Main St.
Waterbury,  CT  06706
Correspondent Contact JOHN RICCIO
Regulation Number888.3040
Classification Product Code
HWC  
Date Received06/20/2008
Decision Date 05/20/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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