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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 K110650
Device Name ZYSTON ARC INTERBODY SPACER
Applicant
Biomet Spine (Aka Ebi, LLC)
100 Interpace Pkwy.
Parsippany,  NJ  07054
Applicant Contact MARGARET F CROWE
Correspondent
Biomet Spine (Aka Ebi, LLC)
100 Interpace Pkwy.
Parsippany,  NJ  07054
Correspondent Contact MARGARET F CROWE
Regulation Number888.3080
Classification Product Code
MAX  
Date Received03/04/2011
Decision Date 06/30/2011
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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