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FDA approves Cordis Selution SLR, the first sirolimus drug-eluting balloon sold in the US FDA panel takes up GRAIL's Galleri cancer screening PMA on September 23 FDA folds the human factors guidance into eSTAR 7.1 and widens PreSTAR to five more meeting types AVAVA raises $45M with a third of it in debt from its lead investor UpFront Diagnostics wins a CE mark for a 10-minute stroke blood test Ambu pays $45M upfront for TIMS Medical and about 7,000 US hospital installs Citi downgrades Boston Scientific over the cyberattack recovery Autonomix puts Medtronic's former chief regulatory counsel on its board FDA calls the NOxBOXi oxygen leak fix a Class II correction, three years after a Class I recall FDA approves Cordis Selution SLR, the first sirolimus drug-eluting balloon sold in the US FDA panel takes up GRAIL's Galleri cancer screening PMA on September 23 FDA folds the human factors guidance into eSTAR 7.1 and widens PreSTAR to five more meeting types AVAVA raises $45M with a third of it in debt from its lead investor UpFront Diagnostics wins a CE mark for a 10-minute stroke blood test Ambu pays $45M upfront for TIMS Medical and about 7,000 US hospital installs Citi downgrades Boston Scientific over the cyberattack recovery Autonomix puts Medtronic's former chief regulatory counsel on its board FDA calls the NOxBOXi oxygen leak fix a Class II correction, three years after a Class I recall

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).

Bone Solutions, Inc. has one other decision in the tracker over the last 12 months: K251522 (Mg OSTEOINJECT; Mg OSTEOREVIVE; Mg OSTEOCRETE).

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

Sources