FDA 510(k)

Axis Charcot Fixation System, 4.5 to 8.5mm Screw System

K-Number: K171018 · 2017-07-13

Decision Date2017-07-13

Product CodeHWC

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Axis Charcot Fixation System, 4.5 to 8.5mm Screw System is a medical device manufactured by Extremity Medical, LLC. It received FDA 510(k) clearance on 2017-07-13 under approval number K171018. 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 Axis Charcot Fixation System, 4.5 to 8.5mm Screw System?

Axis Charcot Fixation System, 4.5 to 8.5mm Screw System is a medical device that received FDA 510(k) clearance on 2017-07-13. It is manufactured by Extremity Medical, LLC. The 510(k) number is K171018.

When was Axis Charcot Fixation System, 4.5 to 8.5mm Screw System approved by the FDA?

Axis Charcot Fixation System, 4.5 to 8.5mm Screw System received FDA 510(k) clearance on 2017-07-13, under approval number K171018.

What company makes Axis Charcot Fixation System, 4.5 to 8.5mm Screw System?

Axis Charcot Fixation System, 4.5 to 8.5mm Screw System is manufactured by Extremity Medical, LLC.

What is the FDA product code for Axis Charcot Fixation System, 4.5 to 8.5mm Screw System?

The FDA product code for Axis Charcot Fixation System, 4.5 to 8.5mm 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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Related Devices (Code: HWC)

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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.