510(k) K063124

INTEGRA MOZAIK BONE REGENERATION MATRIX - STRIPS by Integra Lifesciences Corp. — Product Code MQV

K063124 is an FDA 510(k) premarket notification submitted by Integra Lifesciences Corp. for the device "INTEGRA MOZAIK BONE REGENERATION MATRIX - STRIPS". The FDA issued a decision of Substantially Equivalent on January 19, 2007. The device falls under product code MQV (Filler, Bone Void, Calcium Compound), a Class II device regulated under 21 CFR 888.3045. Integra Lifesciences Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 19, 2007
Date Received
October 13, 2006
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