FDA 510(k)

HYALEX® MTP Hemiarthroplasty Implant

Número K: K250074 · 2026-04-03

Data da decisão2026-04-03

Código do produtoKWD

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

HYALEX® MTP Hemiarthroplasty Implant is the device name listed in this FDA 510(k) record. The listed applicant is Hyalex Orthopaedics, Inc.. It received FDA 510(k) clearance on 2026-04-03 under 510(k) number K250074. The device is classified under product code KWD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the HYALEX® MTP Hemiarthroplasty Implant?

HYALEX® MTP Hemiarthroplasty Implant is a medical device that received FDA 510(k) clearance on 2026-04-03. The listed applicant is Hyalex Orthopaedics, Inc.. The 510(k) number is K250074.

When did HYALEX® MTP Hemiarthroplasty Implant receive FDA 510(k) clearance?

HYALEX® MTP Hemiarthroplasty Implant received FDA 510(k) clearance on 2026-04-03, under 510(k) number K250074.

Who is the listed applicant for HYALEX® MTP Hemiarthroplasty Implant?

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

What is the FDA product code for HYALEX® MTP Hemiarthroplasty Implant?

The FDA product code for HYALEX® MTP Hemiarthroplasty Implant is KWD.

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Dispositivos Relacionados (Código: KWD)

K240268Implante Hemi Accu-JointAccufix Surgical, Inc.K221220Montross Extremity Medical Hemi Implant SystemMontross Extremity Medical K222964BioPoly Lesser Toe Hemiarthroplasty ImplantBioPoly, LLC K201393restor3d MTP ImplantRestor3D, Inc.K203634BioPoly Great Toe Hemiarthroplasty ImplantBioPoly, LLC K200951Implante Hemi Accu-JointAccufix Surgical, Inc.

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