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FDA 510(k)

CERAMENT G

K-Number: K234008 · 2024-03-13

Decision Date2024-03-13
Product CodeQRR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CERAMENT G is the device name listed in this FDA 510(k) record. The listed applicant is Bonesupport AB. It received FDA 510(k) clearance on 2024-03-13 under 510(k) number K234008. The device is classified under product code QRR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CERAMENT G?

CERAMENT G is a medical device that received FDA 510(k) clearance on 2024-03-13. The listed applicant is Bonesupport AB. The 510(k) number is K234008.

When did CERAMENT G receive FDA 510(k) clearance?

CERAMENT G received FDA 510(k) clearance on 2024-03-13, under 510(k) number K234008.

Who is the listed applicant for CERAMENT G?

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

What is the FDA product code for CERAMENT G?

The FDA product code for CERAMENT G is QRR.

Other records listing Bonesupport AB 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.

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.