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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pin, Fixation, Smooth
510(k) Number K863119
Device Name CANNULATED LAG SCREWS
Applicant
Downs Surgical , Ltd.
Pkwy. Close,Pkwy.
Industrial Estate
Sheffield S9 4wj,  GB
Applicant Contact GEOFFREY DOWN
Correspondent
Downs Surgical , Ltd.
Pkwy. Close,Pkwy.
Industrial Estate
Sheffield S9 4wj,  GB
Correspondent Contact GEOFFREY DOWN
Regulation Number888.3040
Classification Product Code
HTY  
Date Received08/14/1986
Decision Date 09/03/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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