Wagner SL Revision Stem Lateral and Wagner Cone Prosthesis System— 510(k) K191781

Name: FDA 510(k) clearance K191781
Creator: U.S. Food and Drug Administration
Published: 2019-08-06

Substantially Equivalent

Zimmer GmbH

FDA 510(k) clearance K191781 for Wagner SL Revision Stem Lateral and Wagner Cone Prosthesis System, Substantially Equivalent on 2019-08-06. Applicant: Zimmer GmbH. Device class: 2.

Clearance details

Applicant: Zimmer GmbH
Product code: Code LZO
Device class: Class 2
Regulation: 21 CFR 888.3353
Advisory panel: Orthopedic
Date received: 2019-07-02
Decision date: 2019-08-06
Decision: Substantially Equivalent
Clearance type: Special
Location: Winterthur, CH

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.