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FDA 510(k)

Mixing and Delivery System

K-Number: K192674 · 2020-02-18

ApplicantBone Solutions, Inc.
Decision Date2020-02-18
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Mixing and Delivery System is a medical device manufactured by Bone Solutions, Inc.. It received FDA 510(k) clearance on 2020-02-18 under approval number K192674. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Mixing and Delivery System?

Mixing and Delivery System is a medical device that received FDA 510(k) clearance on 2020-02-18. It is manufactured by Bone Solutions, Inc.. The 510(k) number is K192674.

When was Mixing and Delivery System approved by the FDA?

Mixing and Delivery System received FDA 510(k) clearance on 2020-02-18, under approval number K192674.

What company makes Mixing and Delivery System?

Mixing and Delivery System is manufactured by Bone Solutions, Inc..

What is the FDA product code for Mixing and Delivery System?

The FDA product code for Mixing and Delivery System is FMF.

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Other Devices by Bone Solutions, Inc.

K161568Bone Solutions Mixing and Delivery System K221256Mg OSTEOINJECT K212991Osteorevive K242372Mg OSTEOREVIVE™, Mg OSTEOCRETE™ K234013Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™ K251522Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™

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Related Devices (Code: FMF)

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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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