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

Name: FDA 510(k) clearance K192683
Creator: U.S. Food and Drug Administration
Published: 2020-02-27

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.. Device class: 2.

Clearance details

Applicant: Biomet UK, Ltd.
Product code: Code LZO
Device class: Class 2
Regulation: 21 CFR 888.3353
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 ↗

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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.