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FDA 510(k)

ACRIFIX

K-Number: K230341 · 2023-04-06

ApplicantDeltamed GmbH
Decision Date2023-04-06
Product CodeEBI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ACRIFIX is a medical device manufactured by Deltamed GmbH. It received FDA 510(k) clearance on 2023-04-06 under approval number K230341. The device is classified under product code EBI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACRIFIX?

ACRIFIX is a medical device that received FDA 510(k) clearance on 2023-04-06. It is manufactured by Deltamed GmbH. The 510(k) number is K230341.

When was ACRIFIX approved by the FDA?

ACRIFIX received FDA 510(k) clearance on 2023-04-06, under approval number K230341.

What company makes ACRIFIX?

ACRIFIX is manufactured by Deltamed GmbH.

What is the FDA product code for ACRIFIX?

The FDA product code for ACRIFIX is EBI.

Other Devices by Deltamed GmbH

K200039P pro Crown & Bridge K2118043Delta Crown K2125413Delta Denture Base - 3Delta Denture Bond - 3Delta Denture Fix K2437203Delta UNlimited

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Official Source

View on FDA Database →

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

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