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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 K093207
Device Name ENDURAMESH, MODEL 762.XXX
Applicant
LUCERO MEDICAL, LLC
PO BOX 67
RICHFIELD,  OH  44286
Applicant Contact JENNIFER PALINCHIK
Correspondent
LUCERO MEDICAL, LLC
PO BOX 67
RICHFIELD,  OH  44286
Correspondent Contact JENNIFER PALINCHIK
Regulation Number888.3060
Classification Product Code
MQP  
Date Received10/13/2009
Decision Date 04/26/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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