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FDA 510(k)

Initia Total Hip System & BIOCERAM AZUL(R) HEAD

K-Number: K160895 · 2016-11-01

ApplicantKyocera Medical Corporation
Decision Date2016-11-01
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Initia Total Hip System & BIOCERAM AZUL(R) HEAD is a medical device manufactured by Kyocera Medical Corporation. It received FDA 510(k) clearance on 2016-11-01 under approval number K160895. The device is classified under product code LZO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Initia Total Hip System & BIOCERAM AZUL(R) HEAD?

Initia Total Hip System & BIOCERAM AZUL(R) HEAD is a medical device that received FDA 510(k) clearance on 2016-11-01. It is manufactured by Kyocera Medical Corporation. The 510(k) number is K160895.

When was Initia Total Hip System & BIOCERAM AZUL(R) HEAD approved by the FDA?

Initia Total Hip System & BIOCERAM AZUL(R) HEAD received FDA 510(k) clearance on 2016-11-01, under approval number K160895.

What company makes Initia Total Hip System & BIOCERAM AZUL(R) HEAD?

Initia Total Hip System & BIOCERAM AZUL(R) HEAD is manufactured by Kyocera Medical Corporation.

What is the FDA product code for Initia Total Hip System & BIOCERAM AZUL(R) HEAD?

The FDA product code for Initia Total Hip System & BIOCERAM AZUL(R) HEAD is LZO.

Related Clinical Trials

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Related PubMed Literature

PMID: 41966529 Comparison of the AccuPower HIV-1 Quant Kit and Aptima HIV-1 Quant Dx Assay for quantification of HIV-1 plasma viral load. Diagnostic microbiology and infectious disease (2026)

Related Devices (Code: LZO)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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