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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 K112014
Device Name ZYSTON STRAIGHT SPACER SYSTEM
Applicant
BIOMET SPINE
100 INTERPACE PARKWAY
parsippany,  NJ  07054
Applicant Contact julie a ryan
Correspondent
BIOMET SPINE
100 INTERPACE PARKWAY
parsippany,  NJ  07054
Correspondent Contact julie a ryan
Regulation Number888.3080
Classification Product Code
MAX  
Subsequent Product Code
MQP  
Date Received07/14/2011
Decision Date 10/17/2011
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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