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FDA 510(k)

Biolox® delta Ceramic Heads, Biolox® delta Option Ceramic Heads MR Labeling

K-Number: K200959 · 2020-07-29

ApplicantBiomet UK, Ltd.
Decision Date2020-07-29
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Biolox® delta Ceramic Heads, Biolox® delta Option Ceramic Heads MR Labeling is a medical device manufactured by Biomet UK, Ltd.. It received FDA 510(k) clearance on 2020-07-29 under approval number K200959. 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 Heads, Biolox® delta Option Ceramic Heads MR Labeling?

Biolox® delta Ceramic Heads, Biolox® delta Option Ceramic Heads MR Labeling is a medical device that received FDA 510(k) clearance on 2020-07-29. It is manufactured by Biomet UK, Ltd.. The 510(k) number is K200959.

When was Biolox® delta Ceramic Heads, Biolox® delta Option Ceramic Heads MR Labeling approved by the FDA?

Biolox® delta Ceramic Heads, Biolox® delta Option Ceramic Heads MR Labeling received FDA 510(k) clearance on 2020-07-29, under approval number K200959.

What company makes Biolox® delta Ceramic Heads, Biolox® delta Option Ceramic Heads MR Labeling?

Biolox® delta Ceramic Heads, Biolox® delta Option Ceramic Heads MR Labeling is manufactured by Biomet UK, Ltd..

What is the FDA product code for Biolox® delta Ceramic Heads, Biolox® delta Option Ceramic Heads MR Labeling?

The FDA product code for Biolox® delta Ceramic Heads, Biolox® delta Option Ceramic Heads MR Labeling is LZO.

Other Devices by Biomet UK, Ltd.

K192683Biolox delta Ceramic Heads, Biolox delta Option Ceramic Heads

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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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