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FDA 510(k)

Avenger Radial Head System

K-Number: K212872 · 2021-12-17

ApplicantIn2bones USA, LLC
Decision Date2021-12-17
Product CodeKWI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Avenger Radial Head System is the device name listed in this FDA 510(k) record. The listed applicant is In2bones USA, LLC. It received FDA 510(k) clearance on 2021-12-17 under 510(k) number K212872. The device is classified under product code KWI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Avenger Radial Head System?

Avenger Radial Head System is a medical device that received FDA 510(k) clearance on 2021-12-17. The listed applicant is In2bones USA, LLC. The 510(k) number is K212872.

When did Avenger Radial Head System receive FDA 510(k) clearance?

Avenger Radial Head System received FDA 510(k) clearance on 2021-12-17, under 510(k) number K212872.

Who is the listed applicant for Avenger Radial Head System?

The FDA 510(k) record lists In2bones USA, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Avenger Radial Head System?

The FDA product code for Avenger Radial Head System is KWI.

Other records listing In2bones USA, LLC as applicant

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Related Devices (Code: KWI)

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.

K260624Arthrex Radial Head Replacement SystemArthrex, Inc.K233592BioPoly Radial Head ImplantBioPoly, LLCK231188ALIGN Radial Head SystemSkeletal Dynamics, Inc.K213563DePuy Synthes Radial Head Replacement SystemDePuy SynthesK192754Avenger Radial Head SystemIn2bones USA, LLCK183618Revolution Radial HeadIgnite Orthopedics, Inc.

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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