510(k) K241555

Moldable Bone Void Filler and Moldable Bone Void Filler + CCC by Rti Surgical, Inc. — Product Code MQV

K241555 is an FDA 510(k) premarket notification submitted by Rti Surgical, Inc. for the device "Moldable Bone Void Filler and Moldable Bone Void Filler + CCC". The FDA issued a decision of Substantially Equivalent on February 21, 2025. The device falls under product code MQV (Filler, Bone Void, Calcium Compound), a Class II device regulated under 21 CFR 888.3045. Rti Surgical, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 21, 2025
Date Received
May 31, 2024
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