LINK CEMENTLESS SCREW-IN ACETABULAR CUP— 510(k) K843940

Substantially Equivalent

Waldemar Link GmbH & Co. KG

FDA 510(k) clearance K843940 for LINK CEMENTLESS SCREW-IN ACETABULAR CUP, Substantially Equivalent on 1985-06-03. Applicant: Waldemar Link GmbH & Co. KG.

Clearance details

Applicant: Waldemar Link GmbH & Co. KG
Product code: Code KWA
Advisory panel: Orthopedic
Date received: 1984-10-09
Decision date: 1985-06-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: E. Hanover, NJ, US

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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.