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FDA 510(k)

Arthrex Mini Comprehensive Fixation System - 1.0mm Screws

K-Number: K193156 · 2020-02-10

ApplicantArthrex, Inc.
Decision Date2020-02-10
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Arthrex Mini Comprehensive Fixation System - 1.0mm Screws is a medical device manufactured by Arthrex, Inc.. It received FDA 510(k) clearance on 2020-02-10 under approval number K193156. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Arthrex Mini Comprehensive Fixation System - 1.0mm Screws?

Arthrex Mini Comprehensive Fixation System - 1.0mm Screws is a medical device that received FDA 510(k) clearance on 2020-02-10. It is manufactured by Arthrex, Inc.. The 510(k) number is K193156.

When was Arthrex Mini Comprehensive Fixation System - 1.0mm Screws approved by the FDA?

Arthrex Mini Comprehensive Fixation System - 1.0mm Screws received FDA 510(k) clearance on 2020-02-10, under approval number K193156.

What company makes Arthrex Mini Comprehensive Fixation System - 1.0mm Screws?

Arthrex Mini Comprehensive Fixation System - 1.0mm Screws is manufactured by Arthrex, Inc..

What is the FDA product code for Arthrex Mini Comprehensive Fixation System - 1.0mm Screws?

The FDA product code for Arthrex Mini Comprehensive Fixation System - 1.0mm Screws is HWC. This falls under the Cardiovascular category.

Related Clinical Trials

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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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