Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 a medical device manufactured by Amann Girrbach AG. It received FDA 510(k) clearance on 2019-12-20 under approval 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. It is manufactured by Amann Girrbach AG. The 510(k) number is K191836.

When was Ceramill A-Splint approved by the FDA?

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

What company makes Ceramill A-Splint?

Ceramill A-Splint is manufactured by Amann Girrbach AG.

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

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

Other Devices by Amann Girrbach AG

Related Devices (Code: MQC)

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.