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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 the device name listed in this FDA 510(k) record. The listed applicant is Zimmer Biomet. It received FDA 510(k) clearance on 2025-04-18 under 510(k) 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. The listed applicant is Zimmer Biomet. The 510(k) number is K250834.

When did Zimmer Biomet Ceramic Heads (22.2mm diameter) receive FDA 510(k) clearance?

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

Who is the listed applicant for Zimmer Biomet Ceramic Heads (22.2mm diameter)?

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

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

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.

NCT06089291Persona IQ Cohort StudyACTIVE_NOT_RECRUITINGNCT06920459Zimmer Biomet Shoulder Arthroplasty PMCF StudyRECRUITINGNCT03506334Anterior Vertebral Body Tethering (AVBT) Using Zimmer Biomet Tether System or Dynesys System Components to Treat Pediatric ScoliosisENROLLING_BY_INVITATIONNCT04984291Zimmer Biomet Shoulder Arthroplasty PMCFRECRUITINGNCT05391828Persona MC vs PS RCT With ROSARECRUITINGNCT06388993Marrow Cellution™ vs. Traditional BMA Harvest ProjectRECRUITING

Other records listing Zimmer Biomet 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.

K251834Persona Partial KneeK243571Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained LinersK251620A.L.P.S. Proximal Humerus Plating SystemK243293Zimmer® Persona® Personalized Knee System

Related Devices (Code: LZO)

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.

K261009MobileLink Acetabular Cup System – 40mm ID Inserts (various)Waldemar Link GmbH & Co. KGK260831Z1 Hip SystemZimmer, Inc.K260182Avenir® Müller Stem; Avenir Complete™ Hip SystemZimmer, Inc.K260037implantcast Packaging System UpdateImplantcast GmbHK252401implaFit® short stemsImplantcast GmbHK253171Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem)Maxx Orthopedics, Inc.

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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