BiMobile Instruments (for BiMobile Dual Mobility System)— 510(k) K211567

Name: FDA 510(k) clearance K211567
Creator: U.S. Food and Drug Administration
Published: 2022-06-03

Substantially Equivalent

Waldemar Link GmbH & Co. KG

FDA 510(k) clearance K211567 for BiMobile Instruments (for BiMobile Dual Mobility System), Substantially Equivalent on 2022-06-03. Applicant: Waldemar Link GmbH & Co. KG. Device class: 2.

Clearance details

Applicant: Waldemar Link GmbH & Co. KG
Product code: Code LZO
Device class: Class 2
Regulation: 21 CFR 888.3353
Advisory panel: Orthopedic
Date received: 2021-05-21
Decision date: 2022-06-03
Decision: Substantially Equivalent
Clearance type: Special
Location: Norderstedt, DE

Download summary PDF View on FDA.gov ↗

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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.

Clearance details

Recent devices under product code LZO

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Adverse events under product code LZO