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FDA 510(k)

Biolox® Delta Revision heads

K-Number: K243809 · 2025-03-04

ApplicantLimacorporate
Decision Date2025-03-04
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Biolox® Delta Revision heads is the device name listed in this FDA 510(k) record. The listed applicant is Limacorporate. It received FDA 510(k) clearance on 2025-03-04 under 510(k) number K243809. 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 Revision heads?

Biolox® Delta Revision heads is a medical device that received FDA 510(k) clearance on 2025-03-04. The listed applicant is Limacorporate. The 510(k) number is K243809.

When did Biolox® Delta Revision heads receive FDA 510(k) clearance?

Biolox® Delta Revision heads received FDA 510(k) clearance on 2025-03-04, under 510(k) number K243809.

Who is the listed applicant for Biolox® Delta Revision heads?

The FDA 510(k) record lists Limacorporate as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Biolox® Delta Revision heads?

The FDA product code for Biolox® Delta Revision heads is LZO.

Other records listing Limacorporate as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: LZO)

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Official Source

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

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