INTER-OP DURASUL ACETABULAR INSERTS (4MM)— 510(k) K002575

Name: FDA 510(k) clearance K002575
Creator: U.S. Food and Drug Administration
Published: 2000-11-15

Substantially Equivalent

Sulzer Orthopedics, Inc.

FDA 510(k) clearance K002575 for INTER-OP DURASUL ACETABULAR INSERTS (4MM), Substantially Equivalent on 2000-11-15. Applicant: Sulzer Orthopedics, Inc.. Device class: 2.

Clearance details

Applicant: Sulzer Orthopedics, Inc.
Product code: Code LWJ
Device class: Class 2
Regulation: 21 CFR 888.3360
Advisory panel: Orthopedic
Date received: 2000-08-18
Decision date: 2000-11-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Austin, TX, US

Download summary PDF View on FDA.gov ↗

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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 Sulzer Orthopedics, Inc.

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K022985 — ASCENDENT ACETABULAR SYSTEM2002-12-05
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K020713 — MS-30 LATERAL FEMORAL STEM2002-05-14
K013935 — ALLOFIT ACETABULAR SYSTEM 32MM ALPHA DURASUL INSERTS2001-12-13
K013031 — MOST OPTIONS SYSTEM2001-12-07

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.