HOWMEDICA V40 22MM FEMORAL HEAD— 510(k) K950541

Name: FDA 510(k) clearance K950541
Creator: U.S. Food and Drug Administration
Published: 1995-03-21

Substantially Equivalent

Howmedica Corp.

FDA 510(k) clearance K950541 for HOWMEDICA V40 22MM FEMORAL HEAD, Substantially Equivalent on 1995-03-21. Applicant: Howmedica Corp.. Device class: 2.

Clearance details

Applicant: Howmedica Corp.
Product code: Code LWJ
Device class: Class 2
Regulation: 21 CFR 888.3360
Advisory panel: Orthopedic
Date received: 1995-02-07
Decision date: 1995-03-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rutherford, NJ, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LWJ

view all

K120595 — UNISYN PLUS HIP STEM2012-10-12
K103518 — TRINITY ACETABULAR SYSTEM2011-03-09
K090764 — NOVATION CFS PRESS-FIT AND CEMENTED STEMS2009-04-21
K082146 — METHA SHORT STEM HIP SYSTEM XL FEMORAL HEAD2008-09-09
K070061 — 36MM COCR FEMORAL HEAD AND 36MM ACETABULAR INSERT2007-01-31

More clearances from Howmedica Corp.

view all

K983528 — MICRO DYNAMIC MESH1998-12-23
K983404 — TYPE 3 FEMORAL COMPONENTS1998-12-22
K980925 — DURATION II TIBIAL INSERTS-ETHYLENE OXIDE STERILIZATION1998-12-16
K980926 — DURATION II ACETABULAR COMPONENTS-ETHYLENE OXIDE STERILIZATION1998-12-16
K980626 — DURATION II ACETABULAR COMPONENTS-GAS PLASMA STERILIZATION1998-12-11

Adverse events under product code LWJ

product code LWJ

Injury: 544
Total: 544

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.