APR METASUL ACETABULAR INSERT— 510(k) K993569

Substantially Equivalent

Sulzermedica

FDA 510(k) clearance K993569 for APR METASUL ACETABULAR INSERT, Substantially Equivalent on 1999-12-01. Applicant: Sulzermedica.

Clearance details

Applicant: Sulzermedica
Product code: Code KWA
Advisory panel: Orthopedic
Date received: 1999-10-21
Decision date: 1999-12-01
Decision: Substantially Equivalent
Clearance type: Special
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.