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FDA 510(k)

Global Modular Replacement System

K-Number: K233261 · 2023-12-08

ApplicantHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics
Decision Date2023-12-08
Product CodeJDI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Global Modular Replacement System is the device name listed in this FDA 510(k) record. The listed applicant is Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics. It received FDA 510(k) clearance on 2023-12-08 under 510(k) number K233261. 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?

Global Modular Replacement System is a medical device that received FDA 510(k) clearance on 2023-12-08. The listed applicant is Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics. The 510(k) number is K233261.

When did Global Modular Replacement System receive FDA 510(k) clearance?

Global Modular Replacement System received FDA 510(k) clearance on 2023-12-08, under 510(k) number K233261.

Who is the listed applicant for Global Modular Replacement System?

The FDA 510(k) record lists Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Global Modular Replacement System?

The FDA product code for Global Modular Replacement System is JDI.

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Related Devices (Code: JDI)

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.

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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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