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FDA 510(k)

Arthrex DualCompression Hindfoot Fusion Nail Implant System

K-Number: K221031 · 2022-12-20

ApplicantArthrex, Inc.
Decision Date2022-12-20
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Arthrex DualCompression Hindfoot Fusion Nail Implant System is the device name listed in this FDA 510(k) record. The listed applicant is Arthrex, Inc.. It received FDA 510(k) clearance on 2022-12-20 under 510(k) number K221031. 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 DualCompression Hindfoot Fusion Nail Implant System?

Arthrex DualCompression Hindfoot Fusion Nail Implant System is a medical device that received FDA 510(k) clearance on 2022-12-20. The listed applicant is Arthrex, Inc.. The 510(k) number is K221031.

When did Arthrex DualCompression Hindfoot Fusion Nail Implant System receive FDA 510(k) clearance?

Arthrex DualCompression Hindfoot Fusion Nail Implant System received FDA 510(k) clearance on 2022-12-20, under 510(k) number K221031.

Who is the listed applicant for Arthrex DualCompression Hindfoot Fusion Nail Implant System?

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 DualCompression Hindfoot Fusion Nail Implant System?

The FDA product code for Arthrex DualCompression Hindfoot Fusion Nail Implant System is HSB.

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Related Devices (Code: HSB)

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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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