510(k) K173933

Sorrento Bioglass Bone Graft Substitute by Xenco Medical, LLC — Product Code MQV

K173933 is an FDA 510(k) premarket notification submitted by Xenco Medical, LLC for the device "Sorrento Bioglass Bone Graft Substitute". The FDA issued a decision of Substantially Equivalent on September 13, 2018. The device falls under product code MQV (Filler, Bone Void, Calcium Compound), a Class II device regulated under 21 CFR 888.3045. Xenco Medical, LLC has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 13, 2018
Date Received
December 26, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Filler, Bone Void, Calcium Compound
Device Class
Class II
Regulation Number
888.3045
Review Panel
OR
Submission Type