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The Tracker / September 2026 / K262230

510(k) cleared

Mg OSTEOREVIVE;Mg OSTEOCRETE

Bone Solutions, Inc. · Sep 11, 2026 · K262230

FDA cleared the Mg OSTEOREVIVE;Mg OSTEOCRETE from Bone Solutions, Inc. on Sep 11, 2026 under K262230, a traditional 510(k). The device falls under product code MQV, Filler, Bone Void, Calcium Compound, regulated at 21 CFR 888.3045 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Jun 30, 2026. The decision came 73 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Bone Solutions, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K262230?

K262230 is the FDA 510(k) for Mg OSTEOREVIVE;Mg OSTEOCRETE, submitted by Bone Solutions, Inc.. FDA's decision date was Sep 11, 2026, under product code MQV (Filler, Bone Void, Calcium Compound).

Who makes the Mg OSTEOREVIVE;Mg OSTEOCRETE?

Bone Solutions, Inc., based in Colleyville, TX, is the applicant of record for K262230.

How long did the K262230 review take?

FDA received the submission on Jun 30, 2026 and issued its decision on Sep 11, 2026, 73 days later.

← All decisions in September 2026