510(k) K171284

FIBERGRAFT BG Matrix Bone Graft Substitute by Prosidyan, Inc. — Product Code MQV

K171284 is an FDA 510(k) premarket notification submitted by Prosidyan, Inc. for the device "FIBERGRAFT BG Matrix Bone Graft Substitute". The FDA issued a decision of Substantially Equivalent on June 30, 2017. The device falls under product code MQV (Filler, Bone Void, Calcium Compound), a Class II device regulated under 21 CFR 888.3045. Prosidyan, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 30, 2017
Date Received
May 1, 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