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FDA 510(k)

Modular Rotating Hinge Knee Systems and Compatible Components

K-Number: K223069 · 2023-04-21

ApplicantHowmedica Osteonics Corp., Dba Stryker Orthopaedics
Decision Date2023-04-21
Product CodeKRO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Modular Rotating Hinge Knee Systems and Compatible Components is a medical device manufactured by Howmedica Osteonics Corp., Dba Stryker Orthopaedics. It received FDA 510(k) clearance on 2023-04-21 under approval number K223069. The device is classified under product code KRO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Modular Rotating Hinge Knee Systems and Compatible Components?

Modular Rotating Hinge Knee Systems and Compatible Components is a medical device that received FDA 510(k) clearance on 2023-04-21. It is manufactured by Howmedica Osteonics Corp., Dba Stryker Orthopaedics. The 510(k) number is K223069.

When was Modular Rotating Hinge Knee Systems and Compatible Components approved by the FDA?

Modular Rotating Hinge Knee Systems and Compatible Components received FDA 510(k) clearance on 2023-04-21, under approval number K223069.

What company makes Modular Rotating Hinge Knee Systems and Compatible Components?

Modular Rotating Hinge Knee Systems and Compatible Components is manufactured by Howmedica Osteonics Corp., Dba Stryker Orthopaedics.

What is the FDA product code for Modular Rotating Hinge Knee Systems and Compatible Components?

The FDA product code for Modular Rotating Hinge Knee Systems and Compatible Components is KRO.

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Other Devices by Howmedica Osteonics Corp., Dba Stryker Orthopaedics

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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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