510(k) K081717

TRICOS A RESORBABLE BONE SUBSTITUTE by Baxter Healthcare Corp — Product Code MQV

K081717 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "TRICOS A RESORBABLE BONE SUBSTITUTE". The FDA issued a decision of Substantially Equivalent on October 10, 2008. The device falls under product code MQV (Filler, Bone Void, Calcium Compound), a Class II device regulated under 21 CFR 888.3045. Baxter Healthcare Corp has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 10, 2008
Date Received
June 18, 2008
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