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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
Model PEEK AND TITANIUM
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 (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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