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FDA 510(k)

Zimmer Biomet OSS™ Orthopedic Salvage System OsseoTi® Sleeves and Augments

Número K: K253515 · 2026-08-24

RequerenteBiomet Orthopedics, Inc.
Data da decisão2026-08-24
Código do produtoJDI
Comité consultivoOR
DecisãoSubstantially Equivalent

Resumo do dispositivo

Zimmer Biomet OSS™ Orthopedic Salvage System OsseoTi® Sleeves and Augments is the device name listed in this FDA 510(k) record. The listed applicant is Biomet Orthopedics, Inc.. It received FDA 510(k) clearance on 2026-08-24 under 510(k) number K253515. 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 Zimmer Biomet OSS™ Orthopedic Salvage System OsseoTi® Sleeves and Augments?

Zimmer Biomet OSS™ Orthopedic Salvage System OsseoTi® Sleeves and Augments is a medical device that received FDA 510(k) clearance on 2026-08-24. The listed applicant is Biomet Orthopedics, Inc.. The 510(k) number is K253515.

When did Zimmer Biomet OSS™ Orthopedic Salvage System OsseoTi® Sleeves and Augments receive FDA 510(k) clearance?

Zimmer Biomet OSS™ Orthopedic Salvage System OsseoTi® Sleeves and Augments received FDA 510(k) clearance on 2026-08-24, under 510(k) number K253515.

Who is the listed applicant for Zimmer Biomet OSS™ Orthopedic Salvage System OsseoTi® Sleeves and Augments?

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

What is the FDA product code for Zimmer Biomet OSS™ Orthopedic Salvage System OsseoTi® Sleeves and Augments?

The FDA product code for Zimmer Biomet OSS™ Orthopedic Salvage System OsseoTi® Sleeves and Augments is JDI.

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Dispositivos Relacionados (Código: JDI)

Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.

K253434OSSTM Orthopedic Salvage SystemBiomet, Inc.K252824Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral HeadSignature Orthopaedics Pty, Ltd.K243571Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained LinersZimmer BiometK240783Anthology 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 OrthopaedicsK240418Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics

Fonte oficial

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