Biolox delta Ceramic Heads, Biolox delta Option Ceramic Heads— 510(k) K192683

Substantially Equivalent

Biomet UK, Ltd.

FDA 510(k) clearance K192683 for Biolox delta Ceramic Heads, Biolox delta Option Ceramic Heads, Substantially Equivalent on 2020-02-27. Applicant: Biomet UK, Ltd..

Clearance details

Applicant: Biomet UK, Ltd.
Product code: Code LZO
Advisory panel: Orthopedic
Date received: 2019-09-26
Decision date: 2020-02-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brigend, GB

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.