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FDA 510(k)

TALUS OF VILEX (TOV)

K-Number: K041289 · 2004-08-05

ApplicantVilex, Inc.
Decision Date2004-08-05
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TALUS OF VILEX (TOV) is the device name listed in this FDA 510(k) record. The listed applicant is Vilex, Inc.. It received FDA 510(k) clearance on 2004-08-05 under 510(k) number K041289. 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 TALUS OF VILEX (TOV)?

TALUS OF VILEX (TOV) is a medical device that received FDA 510(k) clearance on 2004-08-05. The listed applicant is Vilex, Inc.. The 510(k) number is K041289.

When did TALUS OF VILEX (TOV) receive FDA 510(k) clearance?

TALUS OF VILEX (TOV) received FDA 510(k) clearance on 2004-08-05, under 510(k) number K041289.

Who is the listed applicant for TALUS OF VILEX (TOV)?

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

What is the FDA product code for TALUS OF VILEX (TOV)?

The FDA product code for TALUS OF VILEX (TOV) is HWC. This falls under the Cardiovascular category.

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Other records listing Vilex, Inc. 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.

K112837VILEX EZ-STAPLE (MEMORY BONE FIXATION STAPLE)K102413FUZE: INTRAMEDULLARY INTERNAL FIXATION NAILK102401HEMI IMPLANT; MINI HEMI IMPLANTK070052MET-HEAD MODEL# MHDD-XX:CC DIAMETER, CC CANNULATIONK052196VILEX X-FIXK041287VILEX BONE PLATE SYSTEM

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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.

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