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Cerasorb Ortho

FDA 510(k)

Class II (US FDA 510(k))

510(k) K031651

by curasan AG

Identifiers

510(k) Number
K031651 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)

Cerasorb Ortho is a resorbable calcium salt bone void filler. It is designed to function as a bone graft material to support bone regeneration.

This device is subject to FDA 510(k) authorization under K031651. It is categorized under the orthopedic advisory committee for regulatory purposes.

Frequently asked questions

What is the primary function of Cerasorb Ortho?

Cerasorb Ortho is a resorbable calcium salt bone void filler. It is specifically designed to function as a bone graft material to provide support for bone regeneration processes.

What is the regulatory status of this bone void filler?

Cerasorb Ortho is subject to FDA 510(k) authorization under K031651. It is categorized under the orthopedic advisory committee for regulatory purposes.

Who is the manufacturer of Cerasorb Ortho?

The device is manufactured by curasan AG, located in Kleinostheim, Germany.

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: MODIFICATION TO CERASORB ORTHO (K031651) — FDA 510 (k) | Innolitics, Modification To Cerasorb Ortho 510 (k) FDA Premarket Notification ..., Cerasorb M: next generation osteobiologic for ortho bone grafting., Orthobiologics - curasan

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
curasan AG

Sources (1)

  • FDA 510(k) K031651 24 fields · synced Sep 22, 2026