ASTEL NON-METAL BACKED ACETABULAR CUP FOR CEMENTED— 510(k) K901240

Substantially Equivalent

Med-Tek Corp.

FDA 510(k) clearance K901240 for ASTEL NON-METAL BACKED ACETABULAR CUP FOR CEMENTED, Substantially Equivalent on 1990-03-26. Applicant: Med-Tek Corp..

Clearance details

Applicant: Med-Tek Corp.
Product code: Code JDI
Advisory panel: Orthopedic
Date received: 1990-03-15
Decision date: 1990-03-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code JDI

product code JDI

Death: 65
Injury: 12,943
Malfunction: 1,681
Total: 14,689

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.