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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 a medical device manufactured by Arthrex, Inc.. It received FDA 510(k) clearance on 2023-07-17 under approval 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. It is manufactured by Arthrex, Inc.. The 510(k) number is K230257.

When was Arthrex Intramedullary Nails approved by the FDA?

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

What company makes Arthrex Intramedullary Nails?

Arthrex Intramedullary Nails is manufactured by Arthrex, Inc..

What is the FDA product code for Arthrex Intramedullary Nails?

The FDA product code for Arthrex Intramedullary Nails is HSB.

Related Clinical Trials

NCT07536581 Time to Healing in Displaced Pediatric Diaphyseal Forearm Fractures Treated With Bioabsorbable Compared to Titanium Intramedullary Nails NOT_YET_RECRUITING

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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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