ALPHA METASUL 28MM AND 32MM ACETABULAR INSERTS, STANDARD AND HOODED— 510(k) K033943

Substantially Equivalent

Centerpulse Orthopedics, Inc.

FDA 510(k) clearance K033943 for ALPHA METASUL 28MM AND 32MM ACETABULAR INSERTS, STANDARD AND HOODED, Substantially Equivalent on 2004-10-18. Applicant: Centerpulse Orthopedics, Inc..

Clearance details

Applicant: Centerpulse Orthopedics, Inc.
Product code: Code KWA
Advisory panel: Orthopedic
Date received: 2003-12-19
Decision date: 2004-10-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Austin, TX, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KWA

product code KWA

Death: 38
Injury: 10,439
Malfunction: 1,862
Total: 12,339

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.