FDA 510(k)

Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee

K-Number: K222056 · 2023-01-26

ApplicantHowmedica Osteonics Corp., Dba Stryker Orthopaedics

Decision Date2023-01-26

Product CodeJDI

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee is a medical device manufactured by Howmedica Osteonics Corp., Dba Stryker Orthopaedics. It received FDA 510(k) clearance on 2023-01-26 under approval number K222056. The device is classified under product code JDI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee?

Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee is a medical device that received FDA 510(k) clearance on 2023-01-26. It is manufactured by Howmedica Osteonics Corp., Dba Stryker Orthopaedics. The 510(k) number is K222056.

When was Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee approved by the FDA?

Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee received FDA 510(k) clearance on 2023-01-26, under approval number K222056.

What company makes Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee?

Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee is manufactured by Howmedica Osteonics Corp., Dba Stryker Orthopaedics.

What is the FDA product code for Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee?

The FDA product code for Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee is JDI.

Related Clinical Trials

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Related PubMed Literature

PMID: 29653650 Comparison of adverse event and device problem rates for transcatheter aortic valve replacement and Mitraclip procedures as reported by the Transcatheter Valve Therapy Registry and the Food and Drug Administration postmarket surveillance data. American heart journal (2018) PMID: 28502278 A NEW HEALTH TECHNOLOGY ASSESSMENT SYSTEM FOR DEVICES: THE FIRST FIVE YEARS. International journal of technology assessment in health care (2017)

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.