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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 Integrated Fixation, Lumbar
510(k) Number K130641
Device Name LOGIC STAND-ALONE INTERVERTEBRAL BODY FUSION DEVICE
Applicant
Binder Biomedical, Inc.
1951 NW 7th Ave., Suite 13135
Miami,  FL  33136
Applicant Contact LAWRENCE BINDER
Correspondent
Binder Biomedical, Inc.
1951 NW 7th Ave., Suite 13135
Miami,  FL  33136
Correspondent Contact LAWRENCE BINDER
Regulation Number888.3080
Classification Product Code
OVD  
Date Received03/11/2013
Decision Date 09/13/2013
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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