FDA 510(k)

Tyber Medical Distal Radius Plating System

K-Number: K232693 · 2023-12-04

Decision Date2023-12-04

Product CodeHRS

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Tyber Medical Distal Radius Plating System is the device name listed in this FDA 510(k) record. The listed applicant is Tyber Medical, LLC. It received FDA 510(k) clearance on 2023-12-04 under 510(k) number K232693. 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 Tyber Medical Distal Radius Plating System?

Tyber Medical Distal Radius Plating System is a medical device that received FDA 510(k) clearance on 2023-12-04. The listed applicant is Tyber Medical, LLC. The 510(k) number is K232693.

When did Tyber Medical Distal Radius Plating System receive FDA 510(k) clearance?

Tyber Medical Distal Radius Plating System received FDA 510(k) clearance on 2023-12-04, under 510(k) number K232693.

Who is the listed applicant for Tyber Medical Distal Radius Plating System?

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

What is the FDA product code for Tyber Medical Distal Radius Plating System?

The FDA product code for Tyber Medical Distal Radius Plating System is HRS.

Other records listing Tyber Medical, LLC 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.