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FDA 510(k)

Comus Locking Plate systems

K-Number: K190842 · 2020-02-03

ApplicantJiangsu Trauhui Medical Instrument Co., Ltd.
Decision Date2020-02-03
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Comus Locking Plate systems is the device name listed in this FDA 510(k) record. The listed applicant is Jiangsu Trauhui Medical Instrument Co., Ltd.. It received FDA 510(k) clearance on 2020-02-03 under 510(k) number K190842. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Comus Locking Plate systems?

Comus Locking Plate systems is a medical device that received FDA 510(k) clearance on 2020-02-03. The listed applicant is Jiangsu Trauhui Medical Instrument Co., Ltd.. The 510(k) number is K190842.

When did Comus Locking Plate systems receive FDA 510(k) clearance?

Comus Locking Plate systems received FDA 510(k) clearance on 2020-02-03, under 510(k) number K190842.

Who is the listed applicant for Comus Locking Plate systems?

The FDA 510(k) record lists Jiangsu Trauhui Medical Instrument Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Comus Locking Plate systems?

The FDA product code for Comus Locking Plate systems is HRS.

Other records listing Jiangsu Trauhui Medical Instrument Co., Ltd. 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.

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Related Devices (Code: HRS)

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.

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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.

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