MUTARS® femoral stem cemented 160 mm and 200 mm— 510(k) K240391

Name: FDA 510(k) clearance K240391
Creator: U.S. Food and Drug Administration
Published: 2024-10-24

Substantially Equivalent

Implantcast GmbH

FDA 510(k) clearance K240391 for MUTARS® femoral stem cemented 160 mm and 200 mm, Substantially Equivalent on 2024-10-24. Applicant: Implantcast GmbH. Device class: 2.

Clearance details

Applicant: Implantcast GmbH
Product code: Code LZO
Device class: Class 2
Regulation: 21 CFR 888.3353
Advisory panel: Orthopedic
Date received: 2024-02-08
Decision date: 2024-10-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Buxtehude, 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.