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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 Interlaminal
510(k) Number K991662
Device Name TITANIUM HARTSHILL SYSTEM
Applicant
Surgicraft , Ltd.
Fishing Line Rd.
Redditch, Worcs.,  GB B97 6HF
Applicant Contact SIMON FITZER
Correspondent
Surgicraft , Ltd.
Fishing Line Rd.
Redditch, Worcs.,  GB B97 6HF
Correspondent Contact SIMON FITZER
Regulation Number888.3050
Classification Product Code
KWP  
Date Received05/14/1999
Decision Date 11/08/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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