510(k) K093207

ENDURAMESH, MODEL 762.XXX by Lucero Medical, LLC — Product Code MQP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 26, 2010
Date Received
October 13, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Spinal Vertebral Body Replacement Device
Device Class
Class II
Regulation Number
888.3060
Review Panel
OR
Submission Type