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FDA 510(k)

Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™

K-Number: K251522 · 2025-10-13

Decision Date2025-10-13
Product CodeMQV
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™ is a medical device manufactured by Bone Solutions, Inc.. It received FDA 510(k) clearance on 2025-10-13 under approval number K251522. The device is classified under product code MQV. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™?

Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™ is a medical device that received FDA 510(k) clearance on 2025-10-13. It is manufactured by Bone Solutions, Inc.. The 510(k) number is K251522.

When was Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™ approved by the FDA?

Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™ received FDA 510(k) clearance on 2025-10-13, under approval number K251522.

What company makes Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™?

Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™ is manufactured by Bone Solutions, Inc..

What is the FDA product code for Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™?

The FDA product code for Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™ is MQV.

Other Devices by Bone Solutions, Inc.

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Related Devices (Code: MQV)

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.