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FDA 510(k)

Avanti Orthopaedics Ulnar Shortening System

K-Number: K211592 · 2021-07-16

ApplicantAvanti Orthopaedics, Inc.
Decision Date2021-07-16
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Avanti Orthopaedics Ulnar Shortening System is the device name listed in this FDA 510(k) record. The listed applicant is Avanti Orthopaedics, Inc.. It received FDA 510(k) clearance on 2021-07-16 under 510(k) number K211592. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Avanti Orthopaedics Ulnar Shortening System?

Avanti Orthopaedics Ulnar Shortening System is a medical device that received FDA 510(k) clearance on 2021-07-16. The listed applicant is Avanti Orthopaedics, Inc.. The 510(k) number is K211592.

When did Avanti Orthopaedics Ulnar Shortening System receive FDA 510(k) clearance?

Avanti Orthopaedics Ulnar Shortening System received FDA 510(k) clearance on 2021-07-16, under 510(k) number K211592.

Who is the listed applicant for Avanti Orthopaedics Ulnar Shortening System?

The FDA 510(k) record lists Avanti Orthopaedics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Avanti Orthopaedics Ulnar Shortening System?

The FDA product code for Avanti Orthopaedics Ulnar Shortening System is HRS.

Other records listing Avanti Orthopaedics, Inc. as applicant

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.

K261145Avanti Distal Elbow ORIF SystemK222967Avanti Orthopaedics 2.2mm and 2.7mm Cannulated Screws, Avanti Orthopaedics 3.2mm and 4.0mm Cannulated ScrewsK191118Avanti Distal Radius and Forearm System

Related Devices (Code: HRS)

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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