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FDA 510(k)

Versalock Rib and Sternum Plates System

K-Number: K232829 · 2024-06-26

ApplicantGM Dos Reis Industria e Comercio Ltda.
Decision Date2024-06-26
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Versalock Rib and Sternum Plates System is a medical device manufactured by GM Dos Reis Industria e Comercio Ltda.. It received FDA 510(k) clearance on 2024-06-26 under approval number K232829. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Versalock Rib and Sternum Plates System?

Versalock Rib and Sternum Plates System is a medical device that received FDA 510(k) clearance on 2024-06-26. It is manufactured by GM Dos Reis Industria e Comercio Ltda.. The 510(k) number is K232829.

When was Versalock Rib and Sternum Plates System approved by the FDA?

Versalock Rib and Sternum Plates System received FDA 510(k) clearance on 2024-06-26, under approval number K232829.

What company makes Versalock Rib and Sternum Plates System?

Versalock Rib and Sternum Plates System is manufactured by GM Dos Reis Industria e Comercio Ltda..

What is the FDA product code for Versalock Rib and Sternum Plates System?

The FDA product code for Versalock Rib and Sternum Plates System is HRS.

Related Clinical Trials

NCT07251881 SuperCable vs. Conventional Steel Wire for Closure After a Median Sternotomy NOT_YET_RECRUITING

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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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