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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name spinal vertebral body replacement device
510(k) Number K122622
Device Name ENDURAMESH
Original Applicant
LUCERO MEDICAL, LLC
33490 pin oak parkway
avon lake,  OH  44012
Original Contact jennifer palinchik
Regulation Number888.3060
Classification Product Code
MQP  
Date Received08/28/2012
Decision Date 09/19/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
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