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Verticor K-Wire System

by Verticor, Ltd.

510(k) K110047

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK110047 Date28 Feb 2011ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
HTY
Device Class
Class II
Regulation
21 CFR Part 888.3040
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Verticor K-Wire System is a medical device intended for the fixation of bone fractures, the fusion of joints, and bone reconstruction. It is also indicated for use in osteotomies when adequate immobilization is present and serves as guide pins for the insertion of other implants.

This system is identified by FDA 510(k) number K110047. It is manufactured by Verticor, Ltd. and is categorized under the orthopedic advisory committee.

Other devices from Verticor, Ltd.

Questions

AI-generated answers, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the primary clinical use of the Verticor K-Wire System?

    This system is intended for the fixation of bone fractures, the fusion of joints, and bone reconstruction. Additionally, it is indicated for use in osteotomies where adequate immobilization is present and serves as guide pins for the insertion of other implants.

  • How is the Verticor K-Wire System classified for regulatory purposes?

    The Verticor K-Wire System is identified under FDA 510(k) number K110047. It is categorized under the orthopedic advisory committee and was determined to be substantially equivalent to existing devices.

  • Who is the manufacturer of the K-Wire System?

    The Verticor K-Wire System is manufactured by Verticor, Ltd., located in Round Rock, Texas.