FDA 510(k)

Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained Liners

Número K: K243571 · 2025-07-31

Data da decisão2025-07-31

Código do produtoJDI

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained Liners is the device name listed in this FDA 510(k) record. The listed applicant is Zimmer Biomet. It received FDA 510(k) clearance on 2025-07-31 under 510(k) number K243571. The device is classified under product code JDI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained Liners?

Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained Liners is a medical device that received FDA 510(k) clearance on 2025-07-31. The listed applicant is Zimmer Biomet. The 510(k) number is K243571.

When did Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained Liners receive FDA 510(k) clearance?

Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained Liners received FDA 510(k) clearance on 2025-07-31, under 510(k) number K243571.

Who is the listed applicant for Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained Liners?

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 Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained Liners?

The FDA product code for Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained Liners is JDI.

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Outros registros que listam Zimmer Biomet como candidato(a)

K261453G7® Acetabular System K251834Persona Partial Knee K251620Sistema de Placa de Humeral Proximal A.L.P.S.K250834Zimmer Biomet Ceramic Heads (22.2mm diameter)K243293Zimmer® Persona® Personalized Knee System

Dispositivos Relacionados (Código: JDI)

K253515Zimmer Biomet OSS™ Orthopedic Salvage System OsseoTi® Sleeves and AugmentsBiomet Orthopedics, Inc.K253434OSSTM Orthopedic Salvage SystemBiomet, Inc.K252824Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral HeadSignature Orthopaedics Pty, Ltd.K240783Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip Stems; Synergy Hip StemsSmith & Nephew, Inc.K241716Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee ComponentHowmedica Osteonics Corp., Dba Stryker Orthopaedics K240418Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics

Fonte oficial

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