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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Appliance, Fixation, Spinal Intervertebral Body
510(k) Number K080646
Device Name C-TEK MAXAN ANTERIOR CERVICAL PLATE SYSTEM
Applicant
BIOMET SPINE
100 INTERPACE PARKWAY
PARSIPPANY,  NJ  07054
Applicant Contact JACQUELYN A HUGHES
Correspondent
BIOMET SPINE
100 INTERPACE PARKWAY
PARSIPPANY,  NJ  07054
Correspondent Contact JACQUELYN A HUGHES
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received03/06/2008
Decision Date 05/02/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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