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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Spinal Vertebral Body Replacement Device
510(k) Number K041617
Device Name STALIF TT
Applicant
Surgicraft , Ltd.
121 W. Chestnut St.
# 3506
Chicago,  IL  60610
Applicant Contact JANET M WEBB
Correspondent
Surgicraft , Ltd.
121 W. Chestnut St.
# 3506
Chicago,  IL  60610
Correspondent Contact JANET M WEBB
Regulation Number888.3060
Classification Product Code
MQP  
Date Received06/15/2004
Decision Date 09/08/2004
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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