FDA 510(k)

Tyber Medical Trauma Screws

K-Number: K192975 · 2020-01-09

Decision Date2020-01-09

Product CodeHWC

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Tyber Medical Trauma Screws 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 2020-01-09 under 510(k) number K192975. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Tyber Medical Trauma Screws?

Tyber Medical Trauma Screws is a medical device that received FDA 510(k) clearance on 2020-01-09. The listed applicant is Tyber Medical, LLC. The 510(k) number is K192975.

When did Tyber Medical Trauma Screws receive FDA 510(k) clearance?

Tyber Medical Trauma Screws received FDA 510(k) clearance on 2020-01-09, under 510(k) number K192975.

Who is the listed applicant for Tyber Medical Trauma Screws?

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 Trauma Screws?

The FDA product code for Tyber Medical Trauma Screws is HWC. This falls under the Cardiovascular category.

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.