510(k) K122622

ENDURAMESH by Lucero Medical, LLC — Product Code MQP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 19, 2012
Date Received
August 28, 2012
Clearance Type
Special
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