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FDA 510(k)

Ceracell Ortho Foam

K-Number: K181721 · 2018-09-17

ApplicantCurasan AG
Decision Date2018-09-17
Product CodeMQV
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Ceracell Ortho Foam is the device name listed in this FDA 510(k) record. The listed applicant is Curasan AG. It received FDA 510(k) clearance on 2018-09-17 under 510(k) number K181721. 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 Ceracell Ortho Foam?

Ceracell Ortho Foam is a medical device that received FDA 510(k) clearance on 2018-09-17. The listed applicant is Curasan AG. The 510(k) number is K181721.

When did Ceracell Ortho Foam receive FDA 510(k) clearance?

Ceracell Ortho Foam received FDA 510(k) clearance on 2018-09-17, under 510(k) number K181721.

Who is the listed applicant for Ceracell Ortho Foam?

The FDA 510(k) record lists Curasan AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Ceracell Ortho Foam?

The FDA product code for Ceracell Ortho Foam is MQV.

Other records listing Curasan AG 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.

K160566Cerasorb Ortho Foam

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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