EPSILON DURASUL CONSTRAINED ACETABULAR LINER— 510(k) K030923

Substantially Equivalent

Centerpulse Orthopedics, Inc.

FDA 510(k) clearance K030923 for EPSILON DURASUL CONSTRAINED ACETABULAR LINER, Substantially Equivalent on 2003-10-03. Applicant: Centerpulse Orthopedics, Inc..

Clearance details

Applicant: Centerpulse Orthopedics, Inc.
Product code: Code KWZ
Advisory panel: Orthopedic
Date received: 2003-03-24
Decision date: 2003-10-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Austin, TX, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KWZ

product code KWZ

Injury: 993
Total: 993

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.