BIOBALL DELTA CERAMIC HEADS, MULTICUP PE INLAY STANDARD— 510(k) K141377

Substantially Equivalent

Merete Medical GmbH

FDA 510(k) clearance K141377 for BIOBALL DELTA CERAMIC HEADS, MULTICUP PE INLAY STANDARD, Substantially Equivalent on 2014-11-21. Applicant: Merete Medical GmbH.

Clearance details

Applicant: Merete Medical GmbH
Product code: Code LZO
Advisory panel: Orthopedic
Date received: 2014-05-27
Decision date: 2014-11-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Berlin, DE

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.