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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
Applicant
SIGNUS MEDIZINTECHNIK GMBH
PO BOX 566
CHESTERLAND,  OH  44026 -2141
Applicant Contact KAREN E WARDEN
Correspondent
SIGNUS MEDIZINTECHNIK GMBH
PO BOX 566
CHESTERLAND,  OH  44026 -2141
Correspondent 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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