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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 K770035
Device Name SCREW, WADSWORTH OLECRANON
Applicant
Orthopedic Equipment Co., Inc.
MI 
Correspondent
Orthopedic Equipment Co., Inc.
MI 
Regulation Number888.3040
Classification Product Code
HWC  
Date Received01/10/1977
Decision Date 01/14/1977
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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