SC, CEMENTLESS HIP SYSTEM— 510(k) K962034

Name: FDA 510(k) clearance K962034
Creator: U.S. Food and Drug Administration
Published: 1996-10-23

Substantially Equivalent

Artos Medical Products GmbH

FDA 510(k) clearance K962034 for SC, CEMENTLESS HIP SYSTEM, Substantially Equivalent on 1996-10-23. Applicant: Artos Medical Products GmbH. Device class: 2.

Clearance details

Applicant: Artos Medical Products GmbH
Product code: Code LWJ
Device class: Class 2
Regulation: 21 CFR 888.3360
Advisory panel: Orthopedic
Date received: 1996-05-24
Decision date: 1996-10-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

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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 Artos Medical Products GmbH

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K962268 — CHROME COBALT BALL HEAD1996-10-23
K962086 — CPS, CEMENTED CUP SYSTEM1996-08-07
K961899 — CPS, CEMENTED HIP SYSTEM1996-08-01

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.