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FDA 510(k)

Arthrex Mini Comprehensive Fixation System – 1.4mm & 1.6mm Module

K-Number: K191326 · 2019-10-15

ApplicantArthrex, Inc.
Decision Date2019-10-15
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Arthrex Mini Comprehensive Fixation System – 1.4mm & 1.6mm Module is the device name listed in this FDA 510(k) record. The listed applicant is Arthrex, Inc.. It received FDA 510(k) clearance on 2019-10-15 under 510(k) number K191326. 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 Arthrex Mini Comprehensive Fixation System – 1.4mm & 1.6mm Module?

Arthrex Mini Comprehensive Fixation System – 1.4mm & 1.6mm Module is a medical device that received FDA 510(k) clearance on 2019-10-15. The listed applicant is Arthrex, Inc.. The 510(k) number is K191326.

When did Arthrex Mini Comprehensive Fixation System – 1.4mm & 1.6mm Module receive FDA 510(k) clearance?

Arthrex Mini Comprehensive Fixation System – 1.4mm & 1.6mm Module received FDA 510(k) clearance on 2019-10-15, under 510(k) number K191326.

Who is the listed applicant for Arthrex Mini Comprehensive Fixation System – 1.4mm & 1.6mm Module?

The FDA 510(k) record lists Arthrex, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Arthrex Mini Comprehensive Fixation System – 1.4mm & 1.6mm Module?

The FDA product code for Arthrex Mini Comprehensive Fixation System – 1.4mm & 1.6mm Module is HRS.

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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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