Initia Total Hip System & BIOCERAM AZUL(R) HEAD— 510(k) K160895

Substantially Equivalent

Kyocera Medical Corporation

FDA 510(k) clearance K160895 for Initia Total Hip System & BIOCERAM AZUL(R) HEAD, Substantially Equivalent on 2016-11-01. Applicant: Kyocera Medical Corporation.

Clearance details

Applicant: Kyocera Medical Corporation
Product code: Code LZO
Advisory panel: Orthopedic
Date received: 2016-03-31
Decision date: 2016-11-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Yodogawa-Ku, JP

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.