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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 K021030
Device Name TITANIUM CANNULATED INTERFERENCE SCREW
Applicant
FUTURE MEDICAL SYSTEMS, INC.
504 MCCORMICK DR., SUITE T
GLEN BURNIE,  MD  21061
Applicant Contact PATRICK JANIN
Correspondent
FUTURE MEDICAL SYSTEMS, INC.
504 MCCORMICK DR., SUITE T
GLEN BURNIE,  MD  21061
Correspondent Contact PATRICK JANIN
Regulation Number888.3040
Classification Product Code
HWC  
Date Received03/29/2002
Decision Date 06/25/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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