FDA 510(k)

VOLT™ Ankle Trauma 2.7/3.5 Plating System; VOLT™ Calcaneus 2.7 Plating System

Número K: K254054 · 2026-03-02

Data da decisão2026-03-02

Código do produtoHRS

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

VOLT™ Ankle Trauma 2.7/3.5 Plating System; VOLT™ Calcaneus 2.7 Plating System is the device name listed in this FDA 510(k) record. The listed applicant is Synthes GmbH. It received FDA 510(k) clearance on 2026-03-02 under 510(k) number K254054. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the VOLT™ Ankle Trauma 2.7/3.5 Plating System; VOLT™ Calcaneus 2.7 Plating System?

VOLT™ Ankle Trauma 2.7/3.5 Plating System; VOLT™ Calcaneus 2.7 Plating System is a medical device that received FDA 510(k) clearance on 2026-03-02. The listed applicant is Synthes GmbH. The 510(k) number is K254054.

When did VOLT™ Ankle Trauma 2.7/3.5 Plating System; VOLT™ Calcaneus 2.7 Plating System receive FDA 510(k) clearance?

VOLT™ Ankle Trauma 2.7/3.5 Plating System; VOLT™ Calcaneus 2.7 Plating System received FDA 510(k) clearance on 2026-03-02, under 510(k) number K254054.

Who is the listed applicant for VOLT™ Ankle Trauma 2.7/3.5 Plating System; VOLT™ Calcaneus 2.7 Plating System?

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

What is the FDA product code for VOLT™ Ankle Trauma 2.7/3.5 Plating System; VOLT™ Calcaneus 2.7 Plating System?

The FDA product code for VOLT™ Ankle Trauma 2.7/3.5 Plating System; VOLT™ Calcaneus 2.7 Plating System is HRS.

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Outros registros que listam Synthes GmbH como candidato(a)

K254093DePuy Synthes VOLT™ Medial Distal Femur 3.5 Plating System K260069DePuy Synthes VOLT™ Proximal Tibia 3.5 Plating System K243715Synthes Patient Specific Implants K241927Synthes Graphic Case & Tray System K233994VOLT™ Proximal Humerus 3.5 Plating System K233967DePuy Synthes MatrixSTERNUM Fixation System

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Dispositivos Relacionados (Código: HRS)

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Fonte oficial

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