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FDA 510(k)

Arthrex Mini Comprehensive Fixation System – 2.0mm & 2.4mm Module

K-Number: K191344 · 2019-10-03

ApplicantArthrex, Inc.
Decision Date2019-10-03
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Arthrex Mini Comprehensive Fixation System – 2.0mm & 2.4mm Module is a medical device manufactured by Arthrex, Inc.. It received FDA 510(k) clearance on 2019-10-03 under approval number K191344. 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 – 2.0mm & 2.4mm Module?

Arthrex Mini Comprehensive Fixation System – 2.0mm & 2.4mm Module is a medical device that received FDA 510(k) clearance on 2019-10-03. It is manufactured by Arthrex, Inc.. The 510(k) number is K191344.

When was Arthrex Mini Comprehensive Fixation System – 2.0mm & 2.4mm Module approved by the FDA?

Arthrex Mini Comprehensive Fixation System – 2.0mm & 2.4mm Module received FDA 510(k) clearance on 2019-10-03, under approval number K191344.

What company makes Arthrex Mini Comprehensive Fixation System – 2.0mm & 2.4mm Module?

Arthrex Mini Comprehensive Fixation System – 2.0mm & 2.4mm Module is manufactured by Arthrex, Inc..

What is the FDA product code for Arthrex Mini Comprehensive Fixation System – 2.0mm & 2.4mm Module?

The FDA product code for Arthrex Mini Comprehensive Fixation System – 2.0mm & 2.4mm Module is HRS.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT07277946 AtraUmatic Laparoscopic HerNia Repair Clinical Investigation to Evaluate the Safety and Performance of The ECLIPSIUM System for Mesh Fixation IDE RECRUITING NCT06385392 Continuous Wearable Monitor for the Detection and Release of Freezing of Gait. COMPLETED NCT07523620 Comprehensive LEFt Atrial Appendage Occlusion With Rhythm Restoration RECRUITING NCT07034521 The Feasibility and Therapeutic Effect of Hybrid End-effector Robot-assisted Gait Training With an Active-assisted Module in Chronic Stroke Survivors RECRUITING NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION

Related PubMed Literature

PMID: 41734979 Strategies to Increase Patients' Adherence to Digital Therapeutics for Musculoskeletal Diseases: A Narrative Review. Yonsei medical journal (2026)

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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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