PINNACLETM Constrained Acetabular Liners— 510(k) K240639

Substantially Equivalent

Depuy Ireland UC

FDA 510(k) clearance K240639 for PINNACLETM Constrained Acetabular Liners, Substantially Equivalent on 2024-04-04. Applicant: Depuy Ireland UC.

Clearance details

Applicant: Depuy Ireland UC
Product code: Code KWZ
Advisory panel: Orthopedic
Date received: 2024-03-06
Decision date: 2024-04-04
Decision: Substantially Equivalent
Clearance type: Special
Location: Cork, GB

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.