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FDA 510(k)

EXPERT - Flexible Joint Fixation System

K-Number: K242311 · 2024-11-01

ApplicantGM Dos Reis Industria e Comercio Ltda.
Decision Date2024-11-01
Product CodeHTN
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

EXPERT - Flexible Joint Fixation System is a medical device manufactured by GM Dos Reis Industria e Comercio Ltda.. It received FDA 510(k) clearance on 2024-11-01 under approval number K242311. The device is classified under product code HTN. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EXPERT - Flexible Joint Fixation System?

EXPERT - Flexible Joint Fixation System is a medical device that received FDA 510(k) clearance on 2024-11-01. It is manufactured by GM Dos Reis Industria e Comercio Ltda.. The 510(k) number is K242311.

When was EXPERT - Flexible Joint Fixation System approved by the FDA?

EXPERT - Flexible Joint Fixation System received FDA 510(k) clearance on 2024-11-01, under approval number K242311.

What company makes EXPERT - Flexible Joint Fixation System?

EXPERT - Flexible Joint Fixation System is manufactured by GM Dos Reis Industria e Comercio Ltda..

What is the FDA product code for EXPERT - Flexible Joint Fixation System?

The FDA product code for EXPERT - Flexible Joint Fixation System is HTN.

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Related PubMed Literature

PMID: 37365092 Comparison of the international regulations for medical devices-USA versus Europe. Injury (2023)

Other Devices by GM Dos Reis Industria e Comercio Ltda.

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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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