K200959

Substantially Equivalent

Biolox® delta Ceramic Heads, Biolox® delta Option Ceramic Heads MR Labeling

Applicant: Biomet UK, Ltd.
Product code: LZO
Advisory panel: Orthopedic
Date received: 2020-04-10
Decision date: 2020-07-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brigend, GB

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.