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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 K810205
Device Name MECRON CANCELLOUS CANNULATED BONE SCREWS
Applicant
SERRANO INTL.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
SERRANO INTL.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number888.3040
Classification Product Code
HWC  
Date Received01/26/1981
Decision Date 02/09/1981
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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