FDA 510(k)

OSSTM Orthopedic Salvage System

N.º K: K253434 · 2026-07-01

Fecha de decisión2026-07-01

Código de productoJDI

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

OSSTM Orthopedic Salvage System is the device name listed in this FDA 510(k) record. The listed applicant is Biomet, Inc.. It received FDA 510(k) clearance on 2026-07-01 under 510(k) number K253434. The device is classified under product code JDI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the OSSTM Orthopedic Salvage System?

OSSTM Orthopedic Salvage System is a medical device that received FDA 510(k) clearance on 2026-07-01. The listed applicant is Biomet, Inc.. The 510(k) number is K253434.

When did OSSTM Orthopedic Salvage System receive FDA 510(k) clearance?

OSSTM Orthopedic Salvage System received FDA 510(k) clearance on 2026-07-01, under 510(k) number K253434.

Who is the listed applicant for OSSTM Orthopedic Salvage System?

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

What is the FDA product code for OSSTM Orthopedic Salvage System?

The FDA product code for OSSTM Orthopedic Salvage System is JDI.

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Otros registros que enlistan a Biomet, Inc. como solicitante

K251270Taperloc® Complete Hip Stem K241014Biomet Kirschner Wires (K-Wires)K222760StageOne™ Select Hip Cement Spacer Molds K221968StageOne™ Shoulder Cement Spacer Molds K213287StageOne Knee Cement Spacer Molds K212431Biomet Answer/Impact/Integral Distal Centralizer/Centering Sleeve

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Dispositivos relacionados (Código: JDI)

K253515Zimmer Biomet OSS™ Orthopedic Salvage System OsseoTi® Sleeves and AugmentsBiomet Orthopedics, 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 Biomet K240783Anthology Cuellos de Cadera; Cuellos de Cadera CPCS; Cabezas Femorales; Lineras de acetábulo R3; Cuellos de Cadera Spectron; Cuellos de Cadera SynergySmith & 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

Fuente oficial

Ver en la base de datos de la FDA →

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