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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 the device name listed in this FDA 510(k) record. The listed applicant is GM Dos Reis Industria e Comercio Ltda.. It received FDA 510(k) clearance on 2024-11-01 under 510(k) 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. The listed applicant is GM Dos Reis Industria e Comercio Ltda.. The 510(k) number is K242311.

When did EXPERT - Flexible Joint Fixation System receive FDA 510(k) clearance?

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

Who is the listed applicant for EXPERT - Flexible Joint Fixation System?

The FDA 510(k) record lists GM Dos Reis Industria e Comercio Ltda. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing GM Dos Reis Industria e Comercio Ltda. as applicant

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Related Devices (Code: HTN)

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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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