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FDA 510(k)

Mei Ceramic Bracket

K-Number: K190608 · 2019-11-04

ApplicantOrthosun Co., Ltd.
Decision Date2019-11-04
Product CodeNJM
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Mei Ceramic Bracket is a medical device manufactured by Orthosun Co., Ltd.. It received FDA 510(k) clearance on 2019-11-04 under approval number K190608. The device is classified under product code NJM. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Mei Ceramic Bracket?

Mei Ceramic Bracket is a medical device that received FDA 510(k) clearance on 2019-11-04. It is manufactured by Orthosun Co., Ltd.. The 510(k) number is K190608.

When was Mei Ceramic Bracket approved by the FDA?

Mei Ceramic Bracket received FDA 510(k) clearance on 2019-11-04, under approval number K190608.

What company makes Mei Ceramic Bracket?

Mei Ceramic Bracket is manufactured by Orthosun Co., Ltd..

What is the FDA product code for Mei Ceramic Bracket?

The FDA product code for Mei Ceramic Bracket is NJM.

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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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