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FDA 510(k)

Arthrex Intramedullary Nails

K-Number: K230257 · 2023-07-17

ApplicantArthrex, Inc.
Decision Date2023-07-17
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Arthrex Intramedullary Nails is the device name listed in this FDA 510(k) record. The listed applicant is Arthrex, Inc.. It received FDA 510(k) clearance on 2023-07-17 under 510(k) number K230257. The device is classified under product code HSB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Arthrex Intramedullary Nails?

Arthrex Intramedullary Nails is a medical device that received FDA 510(k) clearance on 2023-07-17. The listed applicant is Arthrex, Inc.. The 510(k) number is K230257.

When did Arthrex Intramedullary Nails receive FDA 510(k) clearance?

Arthrex Intramedullary Nails received FDA 510(k) clearance on 2023-07-17, under 510(k) number K230257.

Who is the listed applicant for Arthrex Intramedullary Nails?

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 Intramedullary Nails?

The FDA product code for Arthrex Intramedullary Nails is HSB.

Other records listing Arthrex, Inc. as applicant

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Related Devices (Code: HSB)

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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