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

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..

Clearance details

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

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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.