Acetabular Bone Screws (for MobileLink Acetabular Cup System)— 510(k) K192559

Substantially Equivalent

Waldemar Link GmbH & Co. KG

FDA 510(k) clearance K192559 for Acetabular Bone Screws (for MobileLink Acetabular Cup System), Substantially Equivalent on 2019-12-21. Applicant: Waldemar Link GmbH & Co. KG.

Clearance details

Applicant: Waldemar Link GmbH & Co. KG
Product code: Code LZO
Advisory panel: Orthopedic
Date received: 2019-09-17
Decision date: 2019-12-21
Decision: Substantially Equivalent
Clearance type: Special
Location: Norderstedt, DE

Download summary PDF View on FDA.gov ↗

Adverse events under product code LZO

product code LZO

Death: 17
Injury: 12,942
Malfunction: 1,756
Total: 14,715

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.