Biolox® Delta Revision heads— 510(k) K243809

Substantially Equivalent

Limacorporate

FDA 510(k) clearance K243809 for Biolox® Delta Revision heads, Substantially Equivalent on 2025-03-04. Applicant: Limacorporate.

Clearance details

Applicant: Limacorporate
Product code: Code LZO
Advisory panel: Orthopedic
Date received: 2024-12-11
Decision date: 2025-03-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Villanova Di San Daniele Del Friuli, IT

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.