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Lagrange Letournel Total Hip Femoral

by Howmedica Corp.

510(k) K770473

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 NumberK770473 Date17 Mar 1977ClearedStatusActive

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  • Withdrawn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
JDG
Device Class
Class II
Regulation
21 CFR Part 888.3360
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 27 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 Lagrange Letournel Total Hip Femoral is a cemented, metal femoral component prosthesis designed for hip replacement procedures. It serves as a replacement part for the hip joint to restore function and mobility.

This device is classified as a Class II medical device under regulation number 888.3360. It received FDA 510(k) clearance under reference number K770473.

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Questions

AI-generated answers, 27 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 purpose of the Lagrange Letournel Total Hip Femoral?

    This device is a cemented, metal femoral component prosthesis intended for use in hip replacement procedures. It serves as a replacement part for the hip joint to help restore function and mobility to the patient.

  • How is this device classified for regulatory purposes?

    The Lagrange Letournel Total Hip Femoral is classified as a Class II medical device under regulation number 888.3360. It received FDA 510(k) clearance under reference number K770473.

  • What material is used to construct this femoral component?

    The device is constructed from metal and is specifically designed as a cemented prosthesis for total hip replacement applications.