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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 K901814
Device Name MCGRATH ORTHOPAEDIC BONE SCREWS
Applicant
Mcgrath Surgical , Ltd.
Gunstore Rd., Hilsea
Portsmouth, Hampshire
Po3 5hl England,  GB
Applicant Contact MICHAEL MCGRATH
Correspondent
Mcgrath Surgical , Ltd.
Gunstore Rd., Hilsea
Portsmouth, Hampshire
Po3 5hl England,  GB
Correspondent Contact MICHAEL MCGRATH
Regulation Number888.3040
Classification Product Code
HWC  
Date Received04/23/1990
Decision Date 08/21/1990
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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