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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 K051027
Device Name STALIF TT
Applicant
SURGICRAFT LTD.
950 N MICHIGAN AVE. #2202
CHICAGO,  IL  60611
Applicant Contact JANET M WEBB
Correspondent
SURGICRAFT LTD.
950 N MICHIGAN AVE. #2202
CHICAGO,  IL  60611
Correspondent Contact JANET M WEBB
Regulation Number888.3060
Classification Product Code
MQP  
Date Received04/22/2005
Decision Date 06/29/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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