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FDA 510(k)

Javelin Tailor's Bunion Fixation System

K-Number: K202657 · 2020-12-14

ApplicantNvision Biomedical Technologies, Inc.
Decision Date2020-12-14
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Javelin Tailor's Bunion Fixation System is a medical device manufactured by Nvision Biomedical Technologies, Inc.. It received FDA 510(k) clearance on 2020-12-14 under approval number K202657. 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 Javelin Tailor's Bunion Fixation System?

Javelin Tailor's Bunion Fixation System is a medical device that received FDA 510(k) clearance on 2020-12-14. It is manufactured by Nvision Biomedical Technologies, Inc.. The 510(k) number is K202657.

When was Javelin Tailor's Bunion Fixation System approved by the FDA?

Javelin Tailor's Bunion Fixation System received FDA 510(k) clearance on 2020-12-14, under approval number K202657.

What company makes Javelin Tailor's Bunion Fixation System?

Javelin Tailor's Bunion Fixation System is manufactured by Nvision Biomedical Technologies, Inc..

What is the FDA product code for Javelin Tailor's Bunion Fixation System?

The FDA product code for Javelin Tailor's Bunion Fixation System is HRS.

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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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