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FDA 510(k)

DePuy Synthes Radial Head Replacement System

K-Number: K213563 · 2022-03-18

ApplicantDePuy Synthes
Decision Date2022-03-18
Product CodeKWI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

DePuy Synthes Radial Head Replacement System is a medical device manufactured by DePuy Synthes. It received FDA 510(k) clearance on 2022-03-18 under approval number K213563. 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 DePuy Synthes Radial Head Replacement System?

DePuy Synthes Radial Head Replacement System is a medical device that received FDA 510(k) clearance on 2022-03-18. It is manufactured by DePuy Synthes. The 510(k) number is K213563.

When was DePuy Synthes Radial Head Replacement System approved by the FDA?

DePuy Synthes Radial Head Replacement System received FDA 510(k) clearance on 2022-03-18, under approval number K213563.

What company makes DePuy Synthes Radial Head Replacement System?

DePuy Synthes Radial Head Replacement System is manufactured by DePuy Synthes.

What is the FDA product code for DePuy Synthes Radial Head Replacement System?

The FDA product code for DePuy Synthes Radial Head Replacement 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 K212872Avenger Radial Head SystemIn2bones USA, LLC 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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