510(k) K182074

Mineral Collagen Composite Bioactive Moldable by Collagen Matrix, Inc. — Product Code MQV

K182074 is an FDA 510(k) premarket notification submitted by Collagen Matrix, Inc. for the device "Mineral Collagen Composite Bioactive Moldable". The FDA issued a decision of Substantially Equivalent on March 21, 2019. The device falls under product code MQV (Filler, Bone Void, Calcium Compound), a Class II device regulated under 21 CFR 888.3045. Collagen Matrix, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 21, 2019
Date Received
August 1, 2018
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