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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 the device name listed in this FDA 510(k) record. The listed applicant is Nvision Biomedical Technologies, Inc.. It received FDA 510(k) clearance on 2020-12-14 under 510(k) 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. The listed applicant is Nvision Biomedical Technologies, Inc.. The 510(k) number is K202657.

When did Javelin Tailor's Bunion Fixation System receive FDA 510(k) clearance?

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

Who is the listed applicant for Javelin Tailor's Bunion Fixation System?

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

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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