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FDA 510(k)

ARTHREX COMPRESSION FT SCREWS

K-Number: K132217 · 2013-11-25

ApplicantArthrex, Inc.
Decision Date2013-11-25
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ARTHREX COMPRESSION 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 2013-11-25 under 510(k) number K132217. 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 COMPRESSION FT SCREWS?

ARTHREX COMPRESSION FT SCREWS is a medical device that received FDA 510(k) clearance on 2013-11-25. The listed applicant is Arthrex, Inc.. The 510(k) number is K132217.

When did ARTHREX COMPRESSION FT SCREWS receive FDA 510(k) clearance?

ARTHREX COMPRESSION FT SCREWS received FDA 510(k) clearance on 2013-11-25, under 510(k) number K132217.

Who is the listed applicant for ARTHREX COMPRESSION 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 COMPRESSION FT SCREWS?

The FDA product code for ARTHREX COMPRESSION FT SCREWS is HWC. This falls under the Cardiovascular category.

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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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