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Mineral Collagen Composite Bioactive Moldable Bone Graft Matrix

FDA 510(k)

Class II (US FDA 510(k))

510(k) K240424

by Collagen Matrix, Inc.

Identifiers

510(k) Number
K240424 FDA 510(k)
FDA Product Code
MQV FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 888.3045 FDA 510(k)
Regulation Number
888.3045 FDA 510(k)
Advisory Committee
Orthopedic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Mineral Collagen Composite Bioactive Moldable Bone Graft Matrix is a bone void filler designed for use in gaps or voids that are not intrinsic to the stability of the bony structure. It is composed of a mineral and collagen composite and is intended to be packed into skeletal defects, including those in the extremities, pelvis, intervertebral disc space, and posterolateral spine.

This device is supplied for surgical use in defects that may be surgically created. It has received FDA 510(k) clearance under the product code MQV. Users should refer to the specific product documentation for details regarding storage, sterility, and handling instructions.

Frequently asked questions

What is the intended use of the Mineral Collagen Composite Bone Graft Matrix?

This device is designed as a bone void filler for gaps or voids in the skeletal system that are not intrinsic to the stability of the bony structure. It is intended to be packed into surgically created defects, including those located in the extremities, pelvis, intervertebral disc space, and the posterolateral spine.

What is the regulatory status of this bone graft matrix?

The Mineral Collagen Composite Bioactive Moldable Bone Graft Matrix has received FDA 510(k) clearance under the K240424 submission. It is classified under product code MQV and was determined to be substantially equivalent to existing devices by the orthopedic advisory committee.

How should the device be handled and stored?

Users should consult the specific product documentation provided by Collagen Matrix, Inc. for detailed instructions regarding the proper storage, sterility, and handling of the matrix to ensure it remains suitable for surgical use.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Mineral Collagen Composite Bioactive Moldable Bone Graft Matrix ..., PDF OssiMend® Bioactive Moldable Brochure - regenity.com, Mineral Collagen Composite Bioactive Moldable Bone… - FDA.report

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Collagen Matrix, Inc.

Sources (1)

  • FDA 510(k) K240424 24 fields · synced Sep 27, 2026