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FDA 510(k)

Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™

K-Number: K234013 · 2024-02-05

ApplicantBone Solutions, Inc.
Decision Date2024-02-05
Product CodeMQV
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™ is the device name listed in this FDA 510(k) record. The listed applicant is Bone Solutions, Inc.. It received FDA 510(k) clearance on 2024-02-05 under 510(k) number K234013. 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 2024-02-05. The listed applicant is Bone Solutions, Inc.. The 510(k) number is K234013.

When did Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™ receive FDA 510(k) clearance?

Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™ received FDA 510(k) clearance on 2024-02-05, under 510(k) number K234013.

Who is the listed applicant for Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™?

The FDA 510(k) record lists Bone Solutions, Inc. as the applicant. This does not by itself establish the device manufacturer.

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 records listing Bone Solutions, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251522Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™K242372Mg OSTEOREVIVE™, Mg OSTEOCRETE™K221256Mg OSTEOINJECTK212991OsteoreviveK192674Mixing and Delivery SystemK161568Bone Solutions Mixing and Delivery System

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Related Devices (Code: MQV)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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.

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