Lagrange Letournel Total Hip Femoral
510(k) K770473
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK770473 | Date17 Mar 1977 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 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
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.
Other devices from Howmedica Corp.
Questions
AI-generated answers, 27 Sep 2026
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.