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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthosis, Spine, Plate, Laminoplasty, Metal
510(k) Number K100805
Device Name GALLERY LAMINOPLASTY FIXATION SYSTEM
Applicant
Biomet Spine (Aka Ebi, LLC)
100 Interpace Pkwy.
Parsippany,  NJ  07054
Applicant Contact SHIKHA GOLA
Correspondent
Biomet Spine (Aka Ebi, LLC)
100 Interpace Pkwy.
Parsippany,  NJ  07054
Correspondent Contact SHIKHA GOLA
Regulation Number888.3050
Classification Product Code
NQW  
Date Received03/22/2010
Decision Date 07/20/2010
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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