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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 a medical device manufactured by In2bones USA, LLC. It received FDA 510(k) clearance on 2021-12-17 under approval 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. It is manufactured by In2bones USA, LLC. The 510(k) number is K212872.

When was Avenger Radial Head System approved by the FDA?

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

What company makes Avenger Radial Head System?

Avenger Radial Head System is manufactured by In2bones USA, LLC.

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

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

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Related Devices (Code: KWI)

K172688Align Radial Head SystemSkeletal Dynamics, LLC K183618Revolution Radial HeadIgnite Orthopedics, Inc. K192754Avenger Radial Head SystemIn2bones USA, LLC K213563DePuy Synthes Radial Head Replacement SystemDePuy Synthes K231188ALIGN Radial Head SystemSkeletal Dynamics, Inc. K233592BioPoly Radial Head ImplantBioPoly, LLC

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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