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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Appliance, Fixation, Spinal Intervertebral Body
510(k) Number K853033
Device Name HARTSHILL RECT & WIRES, SPINAL FIXATION SYSTEM
Applicant
A.W. Showell (Surgicraft) , Ltd.
Britten St.
Redditch
Worcs. B97 6hf England,  GB
Applicant Contact A. D SHOWELL
Correspondent
A.W. Showell (Surgicraft) , Ltd.
Britten St.
Redditch
Worcs. B97 6hf England,  GB
Correspondent Contact A. D SHOWELL
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received07/18/1985
Decision Date 09/24/1985
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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