BIOLOX Delta Ceramic Femoral Heads, BIOLOX Option Ceramic Femoral Head System— 510(k) K192416

Substantially Equivalent

Zimmer GmbH

FDA 510(k) clearance K192416 for BIOLOX Delta Ceramic Femoral Heads, BIOLOX Option Ceramic Femoral Head System, Substantially Equivalent on 2019-10-01. Applicant: Zimmer GmbH.

Clearance details

Applicant: Zimmer GmbH
Product code: Code LZO
Advisory panel: Orthopedic
Date received: 2019-09-04
Decision date: 2019-10-01
Decision: Substantially Equivalent
Clearance type: Special
Location: Winterthur, CH

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.