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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 K122317
Device Name TETRIS II
Original Applicant
SIGNUS MEDIZINTECHNIK GMBH
po box 566
chesterland,  OH  44026 -2141
Original Contact karen e warden
Regulation Number888.3080
Classification Product Code
MAX  
Subsequent Product Code
MQP  
Date Received08/01/2012
Decision Date 08/29/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
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