FDA 510(k)

Ceramill A-Splint

K-Number: K191836 · 2019-12-20

Decision Date2019-12-20

Product CodeMQC

DecisionSubstantially Equivalent

Device Summary

Ceramill A-Splint is the device name listed in this FDA 510(k) record. The listed applicant is Amann Girrbach AG. It received FDA 510(k) clearance on 2019-12-20 under 510(k) number K191836. The device is classified under product code MQC. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Ceramill A-Splint?

Ceramill A-Splint is a medical device that received FDA 510(k) clearance on 2019-12-20. The listed applicant is Amann Girrbach AG. The 510(k) number is K191836.

When did Ceramill A-Splint receive FDA 510(k) clearance?

Ceramill A-Splint received FDA 510(k) clearance on 2019-12-20, under 510(k) number K191836.

Who is the listed applicant for Ceramill A-Splint?

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

What is the FDA product code for Ceramill A-Splint?

The FDA product code for Ceramill A-Splint is MQC.

Other records listing Amann Girrbach AG as applicant

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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.