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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 K111792
Device Name MOBIS, MOVAL, SEMIAL, TETRISMODEL PEEK AND TITANIUM, KIMBA MODEL STANDARD AND MINI
Applicant
SIGNUS MEDIZINTECHNIK GMBH
8202 SHERMAN ROAD
CHESTERLAND,  OH  44026 -2141
Applicant Contact KAREN E WARDEN, PHD
Correspondent
SIGNUS MEDIZINTECHNIK GMBH
8202 SHERMAN ROAD
CHESTERLAND,  OH  44026 -2141
Correspondent Contact KAREN E WARDEN, PHD
Regulation Number888.3080
Classification Product Code
MAX  
Subsequent Product Code
MQP  
Date Received06/27/2011
Decision Date 03/05/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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