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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 K081636
Device Name PEEK-OPTIMA ALIF SPACER
Applicant
BIOMET SPINE
100 INTERPACE PARKWAY
PARSIPPANY,  NJ  07054
Applicant Contact VIVIAN KELLY
Correspondent
BIOMET SPINE
100 INTERPACE PARKWAY
PARSIPPANY,  NJ  07054
Correspondent Contact VIVIAN KELLY
Regulation Number888.3080
Classification Product Code
MAX  
Date Received06/11/2008
Decision Date 08/07/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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