Cleared Traditional

Moldable Bone Void Filler and Moldable Bone Void Filler + CCC

K241555 · Rti Surgical, Inc. · Orthopedic
Feb 2025
Decision
266d
Days
Class 2
Risk

About This 510(k) Submission

K241555 is an FDA 510(k) clearance for the Moldable Bone Void Filler and Moldable Bone Void Filler + CCC, a Filler, Bone Void, Calcium Compound (Class II — Special Controls, product code MQV), submitted by Rti Surgical, Inc. (Alachua, US). The FDA issued a Cleared decision on February 21, 2025, 266 days after receiving the submission on May 31, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3045.

Submission Details

510(k) Number K241555 FDA.gov
FDA Decision Cleared SESE
Date Received May 31, 2024
Decision Date February 21, 2025
Days to Decision 266 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code MQV — Filler, Bone Void, Calcium Compound
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3045

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