510(k) K092336

C-THRU SPINAL SYSTEM by Ebi, L.P. — Product Code MQP

K092336 is an FDA 510(k) premarket notification submitted by Ebi, L.P. for the device "C-THRU SPINAL SYSTEM". The FDA issued a decision of Substantially Equivalent on October 15, 2009. The device falls under product code MQP (Spinal Vertebral Body Replacement Device), a Class II device regulated under 21 CFR 888.3060. Ebi, L.P. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 15, 2009
Date Received
August 4, 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