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FDA 510(k)

Zimmer Biomet Ceramic Heads (22.2mm diameter)

K-Number: K250834 · 2025-04-18

ApplicantZimmer Biomet
Decision Date2025-04-18
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Zimmer Biomet Ceramic Heads (22.2mm diameter) is a medical device manufactured by Zimmer Biomet. It received FDA 510(k) clearance on 2025-04-18 under approval number K250834. 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 Zimmer Biomet Ceramic Heads (22.2mm diameter)?

Zimmer Biomet Ceramic Heads (22.2mm diameter) is a medical device that received FDA 510(k) clearance on 2025-04-18. It is manufactured by Zimmer Biomet. The 510(k) number is K250834.

When was Zimmer Biomet Ceramic Heads (22.2mm diameter) approved by the FDA?

Zimmer Biomet Ceramic Heads (22.2mm diameter) received FDA 510(k) clearance on 2025-04-18, under approval number K250834.

What company makes Zimmer Biomet Ceramic Heads (22.2mm diameter)?

Zimmer Biomet Ceramic Heads (22.2mm diameter) is manufactured by Zimmer Biomet.

What is the FDA product code for Zimmer Biomet Ceramic Heads (22.2mm diameter)?

The FDA product code for Zimmer Biomet Ceramic Heads (22.2mm diameter) is LZO.

Related Clinical Trials

NCT06089291 Persona IQ Cohort Study ENROLLING_BY_INVITATION NCT04984291 Zimmer Biomet Shoulder Arthroplasty PMCF RECRUITING NCT07485829 Zimmer Biomet-RibFix Titan RECRUITING NCT06388993 Marrow Cellution™ vs. Traditional BMA Harvest Project RECRUITING

Other Devices by Zimmer Biomet

K243293Zimmer® Persona® Personalized Knee System K251834Persona Partial Knee K243571Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained Liners K251620A.L.P.S. Proximal Humerus Plating System

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

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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