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FDA 510(k)

Axis Charcot Fixation System, 4.5 to 8.5mm Screw System

K-Number: K171018 · 2017-07-13

ApplicantExtremity Medical, LLC
Decision Date2017-07-13
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Axis Charcot Fixation System, 4.5 to 8.5mm Screw System is the device name listed in this FDA 510(k) record. The listed applicant is Extremity Medical, LLC. It received FDA 510(k) clearance on 2017-07-13 under 510(k) 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. The listed applicant is Extremity Medical, LLC. The 510(k) number is K171018.

When did Axis Charcot Fixation System, 4.5 to 8.5mm Screw System receive FDA 510(k) clearance?

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

Who is the listed applicant for Axis Charcot Fixation System, 4.5 to 8.5mm Screw System?

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

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.

Other records listing Extremity Medical, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K250536MetaFore Small Screw SystemK251128Extremity Medical External Fixation SystemK241563Extremity Medical External Fixation SystemK212297Omni Foot and Ankle Plating SystemK211261Axis Charcot Fixation SystemK201556Intraosseous Fixation System

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Related Devices (Code: HWC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262344Large Compression ScrewsTriMed, Inc.K253858GFS - Sterile Screws and Top HatT.A.G. Medical Products Corporation, Ltd.K262075Lapidus Screw KitRelja Innovations, LLCK260809Arthrex Sterile VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.K253108VEOFIX Snap Off ScrewSteps OrthoK261154CoLink® & CoLag® Non-Sterile ScrewsIn2Bones USA, LLC

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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