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FDA 510(k)

Arthrex Low Profile Screws

K-Number: K203239 · 2020-12-30

ApplicantArthrex, Inc.
Decision Date2020-12-30
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Arthrex Low Profile 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 2020-12-30 under 510(k) number K203239. 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 Low Profile Screws?

Arthrex Low Profile Screws is a medical device that received FDA 510(k) clearance on 2020-12-30. The listed applicant is Arthrex, Inc.. The 510(k) number is K203239.

When did Arthrex Low Profile Screws receive FDA 510(k) clearance?

Arthrex Low Profile Screws received FDA 510(k) clearance on 2020-12-30, under 510(k) number K203239.

Who is the listed applicant for Arthrex Low Profile 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 Low Profile Screws?

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

Other records listing Arthrex, Inc. as applicant

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Related Devices (Code: HWC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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