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GDLH Variable Angle Connector

by Danek Group, Inc. 510(k)

Active United States

510(k) K934582

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SN Traditional NumberK934582 Date21 Jun 1994DecidedStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
KWP
Device Class
Class II
Regulation
21 CFR Part 888.3050
Advisory Committee
Orthopedic
FDA Decision
SN

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 GDLH Variable Angle Connector is an orthopedic device designed for use in spinal fixation procedures. It functions as a mechanical component to facilitate the connection and adjustment of spinal instrumentation systems.

This device is identified under FDA 510(k) clearance K934582. It is manufactured by Danek Group, Inc. and is categorized under product code KWP.

Other devices from Danek Group, Inc.

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 function of the GDLH Variable Angle Connector?

    The GDLH Variable Angle Connector is an orthopedic device used during spinal fixation procedures. It serves as a mechanical component that allows for the connection and adjustment of various spinal instrumentation systems.

  • Who is the manufacturer of this spinal connector?

    This device is manufactured by Danek Group, Inc., located in Memphis, Tennessee.

  • What is the regulatory status of the GDLH Variable Angle Connector?

    The device has received FDA 510(k) clearance under the identifier K934582. It is categorized under product code KWP and was reviewed by the Orthopedic advisory committee.