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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 K131372
Device Name MOBIS II
Applicant
Signus Medizintechnik GmbH
P.O. Box 566
Chesterland,  OH  44026 -2141
Applicant Contact KAREN E WARDEN
Correspondent
Signus Medizintechnik GmbH
P.O. Box 566
Chesterland,  OH  44026 -2141
Correspondent Contact KAREN E WARDEN
Regulation Number888.3080
Classification Product Code
MAX  
Date Received05/13/2013
Decision Date 07/02/2013
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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