Cleared Traditional

Mg OSTEOREVIVE?, Mg OSTEOCRETE?

K242372 · Bone Solutions, Inc. · Orthopedic
Oct 2024
Decision
70d
Days
Class 2
Risk

About This 510(k) Submission

K242372 is an FDA 510(k) clearance for the Mg OSTEOREVIVE?, Mg OSTEOCRETE?, a Filler, Bone Void, Calcium Compound (Class II — Special Controls, product code MQV), submitted by Bone Solutions, Inc. (Colleyville, US). The FDA issued a Cleared decision on October 18, 2024, 70 days after receiving the submission on August 9, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3045.

Submission Details

510(k) Number K242372 FDA.gov
FDA Decision Cleared SESE
Date Received August 09, 2024
Decision Date October 18, 2024
Days to Decision 70 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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