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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name intervertebral fusion device with bone graft, lumbar
510(k) Number K121332
Device Name LOOP CAGE
Original Applicant
ADVANCED MEDICAL TECHNOLOGIES AG
1001 oakwood blvd.
round rock,  TX  78681
Original Contact j.d. webb
Regulation Number888.3080
Classification Product Code
MAX  
Date Received05/03/2012
Decision Date 06/29/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
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