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FDA 510(k)

Tangis Anterior Cervical Plate

K-Number: K161524 · 2016-09-02

ApplicantNvision Biomedical Technologies, LLC
Decision Date2016-09-02
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Tangis Anterior Cervical Plate is the device name listed in this FDA 510(k) record. The listed applicant is Nvision Biomedical Technologies, LLC. It received FDA 510(k) clearance on 2016-09-02 under 510(k) number K161524. The device is classified under product code KWQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Tangis Anterior Cervical Plate?

Tangis Anterior Cervical Plate is a medical device that received FDA 510(k) clearance on 2016-09-02. The listed applicant is Nvision Biomedical Technologies, LLC. The 510(k) number is K161524.

When did Tangis Anterior Cervical Plate receive FDA 510(k) clearance?

Tangis Anterior Cervical Plate received FDA 510(k) clearance on 2016-09-02, under 510(k) number K161524.

Who is the listed applicant for Tangis Anterior Cervical Plate?

The FDA 510(k) record lists Nvision Biomedical Technologies, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Tangis Anterior Cervical Plate?

The FDA product code for Tangis Anterior Cervical Plate is KWQ.

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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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