510(k) K161840— LINK® SP-CL® Hip System PoroLink® (microporous) and HX® (CaP) coated & LINK® LCU® Hip System PoroLink® (microporous) and HX® (CaP) coated

Substantially Equivalent

Waldemar Link GmbH & Co. KG

Clearance details

Applicant: Waldemar Link GmbH & Co. KG
Product code: Code LZO
Advisory panel: Orthopedic
Date received: 2016-07-05
Decision date: 2017-03-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Norderstedt, DE

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.