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FDA 510(k)

TACTIX Vector Syndesmosis System

K-Number: K240035 · 2024-08-01

ApplicantVilex, LLC
Decision Date2024-08-01
Product CodeHTN
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TACTIX Vector Syndesmosis System is the device name listed in this FDA 510(k) record. The listed applicant is Vilex, LLC. It received FDA 510(k) clearance on 2024-08-01 under 510(k) number K240035. The device is classified under product code HTN. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TACTIX Vector Syndesmosis System?

TACTIX Vector Syndesmosis System is a medical device that received FDA 510(k) clearance on 2024-08-01. The listed applicant is Vilex, LLC. The 510(k) number is K240035.

When did TACTIX Vector Syndesmosis System receive FDA 510(k) clearance?

TACTIX Vector Syndesmosis System received FDA 510(k) clearance on 2024-08-01, under 510(k) number K240035.

Who is the listed applicant for TACTIX Vector Syndesmosis System?

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

What is the FDA product code for TACTIX Vector Syndesmosis System?

The FDA product code for TACTIX Vector Syndesmosis System is HTN.

Other records listing Vilex, 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.

K260900DYNEX® External Fixation SystemsK250304TITANEX Screw SystemsK240475Hintermann Series H2 Total Ankle SystemK243408TACTIX Vector Syndesmosis SystemK233816REDEMPTION Charcot Plating SystemK231343Redemption Duo Hindfoot Nail System

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Related Devices (Code: HTN)

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.

K253115LARS ACJMovmedix S.A.S.K252081SportLinc Syndesmosis DeviceLincotek MedicalK253727Syndesmosis TightRope PROArthrex, Inc.K251643Synchfix EVTWright Medical Technology, Inc. (Stryker Corporation)K251134RipCordTriMed, Inc.K243624Acu-Sinch Knotless MiniAcumed, 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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