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FDA 510(k)

Arthrex Cannulated Screw System

K-Number: K240815 · 2024-06-13

ApplicantArthrex, Inc.
Decision Date2024-06-13
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Arthrex Cannulated Screw System is a medical device manufactured by Arthrex, Inc.. It received FDA 510(k) clearance on 2024-06-13 under approval number K240815. 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 Cannulated Screw System?

Arthrex Cannulated Screw System is a medical device that received FDA 510(k) clearance on 2024-06-13. It is manufactured by Arthrex, Inc.. The 510(k) number is K240815.

When was Arthrex Cannulated Screw System approved by the FDA?

Arthrex Cannulated Screw System received FDA 510(k) clearance on 2024-06-13, under approval number K240815.

What company makes Arthrex Cannulated Screw System?

Arthrex Cannulated Screw System is manufactured by Arthrex, Inc..

What is the FDA product code for Arthrex Cannulated Screw System?

The FDA product code for Arthrex Cannulated Screw System is HWC. This falls under the Cardiovascular category.

Related Clinical Trials

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Related PubMed Literature

PMID: 38493931 Establishing finite element model credibility of a pedicle screw system under compression-bending: An end-to-end example of the ASME V&V 40 standard. Methods (San Diego, Calif.) (2024) PMID: 37209414 Adverse events associated with Aveir Journal of cardiovascular electrophysiology (2023) PMID: 30035086 Translational research of one dynamic hip screw system-from the SCI to the FDA. Journal of orthopaedic translation (2016)

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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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