FDA 510(k)

Arthrex Beveled FT Screws

K-Number: K210994 · 2021-06-01

Decision Date2021-06-01

Product CodeHWC

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Arthrex Beveled FT Screws is the device name listed in this FDA 510(k) record. The listed applicant is Arthrex, Inc.. It received FDA 510(k) clearance on 2021-06-01 under 510(k) number K210994. 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 Arthrex Beveled FT Screws?

Arthrex Beveled FT Screws is a medical device that received FDA 510(k) clearance on 2021-06-01. The listed applicant is Arthrex, Inc.. The 510(k) number is K210994.

When did Arthrex Beveled FT Screws receive FDA 510(k) clearance?

Arthrex Beveled FT Screws received FDA 510(k) clearance on 2021-06-01, under 510(k) number K210994.

Who is the listed applicant for Arthrex Beveled FT Screws?

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

What is the FDA product code for Arthrex Beveled FT Screws?

The FDA product code for Arthrex Beveled FT Screws is HWC. This falls under the Cardiovascular category.

Other records listing Arthrex, Inc. 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.