FDA 510(k)

Biolox® Delta Revision heads

K-Number: K243809 · 2025-03-04

Decision Date2025-03-04

Product CodeLZO

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Biolox® Delta Revision heads is a medical device manufactured by Limacorporate. It received FDA 510(k) clearance on 2025-03-04 under approval 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. It is manufactured by Limacorporate. The 510(k) number is K243809.

When was Biolox® Delta Revision heads approved by the FDA?

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

What company makes Biolox® Delta Revision heads?

Biolox® Delta Revision heads is manufactured by Limacorporate.

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

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

Other Devices by Limacorporate

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Related Devices (Code: LZO)

K160895Initia Total Hip System & BIOCERAM AZUL(R) HEADKyocera Medical Corporation K161830Zimmer M/L Taper Hip ProsthesisZimmer, Inc. K161192Wagner SL Revision Stem Lateral, Wagner Cone Prosthesis® SystemZimmer GmbH K152893Corin Optimized Positioning System (OPS)Corin USA K160289MasterLoc StemMedacta International K152903REVIVAL(TM) Modular Revision Hip StemCorin USA

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.