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MBCP+

FDA 510(k)

Class II (US FDA 510(k))

510(k) K063527

by Biomatlante

Identifiers

510(k) Number
K063527 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)

MBCP+ is a fully synthetic bone graft matrix used as an alternative to biologic osteoinductive products. It is a 3D interconnected matrix that mimics the trabecular architecture and thin crystalline structure of natural bone. The device provides optimal permeability for cell migration and angiogenesis.

MBCP+ is supplied as granules in 0.5-1.0mm size with 0.25cc volume. It is a synthetic device that has received FDA 510(k) clearance with the product code MQV. The device is intended for use in bone grafting procedures, particularly in the treatment of long bone non-union fractures.

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: Implantiem Shop - Biomatlante MBCP Granules 0.5-1.0mm 0.25cc, Study Results: Biomatlante's MBCP+ Synthetic Bone Graft and MSCs, PDF 510(k) Summary JUL 3 (12007 - Food and Drug Administration

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Biomatlante

Sources (1)

  • FDA 510(k) K063527 24 fields · synced Sep 22, 2026