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FDA 510(k)

BIOLOX Delta Ceramic Femoral Heads, BIOLOX Option Ceramic Femoral Head System

K-Number: K192416 · 2019-10-01

ApplicantZimmer GmbH
Decision Date2019-10-01
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BIOLOX Delta Ceramic Femoral Heads, BIOLOX Option Ceramic Femoral Head System is a medical device manufactured by Zimmer GmbH. It received FDA 510(k) clearance on 2019-10-01 under approval number K192416. 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 BIOLOX Delta Ceramic Femoral Heads, BIOLOX Option Ceramic Femoral Head System?

BIOLOX Delta Ceramic Femoral Heads, BIOLOX Option Ceramic Femoral Head System is a medical device that received FDA 510(k) clearance on 2019-10-01. It is manufactured by Zimmer GmbH. The 510(k) number is K192416.

When was BIOLOX Delta Ceramic Femoral Heads, BIOLOX Option Ceramic Femoral Head System approved by the FDA?

BIOLOX Delta Ceramic Femoral Heads, BIOLOX Option Ceramic Femoral Head System received FDA 510(k) clearance on 2019-10-01, under approval number K192416.

What company makes BIOLOX Delta Ceramic Femoral Heads, BIOLOX Option Ceramic Femoral Head System?

BIOLOX Delta Ceramic Femoral Heads, BIOLOX Option Ceramic Femoral Head System is manufactured by Zimmer GmbH.

What is the FDA product code for BIOLOX Delta Ceramic Femoral Heads, BIOLOX Option Ceramic Femoral Head System?

The FDA product code for BIOLOX Delta Ceramic Femoral Heads, BIOLOX Option Ceramic Femoral Head System is LZO.

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Related PubMed Literature

PMID: 39726899 How to improve the mechanical safety of a novel spinal implant while saving costs and time. JOR spine (2024)

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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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