FDA 510(k)

Minimally Invasive Bunion Plating System

K-Number: K172178 · 2017-11-16

Decision Date2017-11-16

Product CodeHRS

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Minimally Invasive Bunion Plating System is the device name listed in this FDA 510(k) record. The listed applicant is Trilliant Surgical, Ltd.. It received FDA 510(k) clearance on 2017-11-16 under 510(k) number K172178. 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 Minimally Invasive Bunion Plating System?

Minimally Invasive Bunion Plating System is a medical device that received FDA 510(k) clearance on 2017-11-16. The listed applicant is Trilliant Surgical, Ltd.. The 510(k) number is K172178.

When did Minimally Invasive Bunion Plating System receive FDA 510(k) clearance?

Minimally Invasive Bunion Plating System received FDA 510(k) clearance on 2017-11-16, under 510(k) number K172178.

Who is the listed applicant for Minimally Invasive Bunion Plating System?

The FDA 510(k) record lists Trilliant Surgical, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Minimally Invasive Bunion Plating System?

The FDA product code for Minimally Invasive Bunion Plating System is HRS.

Other records listing Trilliant Surgical, Ltd. as applicant

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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.