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FDA 510(k)

DePuy Synthes VOLT™ Medial Distal Femur 3.5 Plating System

K-Number: K254093 · 2026-03-10

ApplicantSynthes GmbH
Decision Date2026-03-10
Product Code
DecisionSubstantially Equivalent

Device Summary

DePuy Synthes VOLT™ Medial Distal Femur 3.5 Plating System is a medical device manufactured by Synthes GmbH. It received FDA 510(k) clearance on 2026-03-10 under approval number K254093. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DePuy Synthes VOLT™ Medial Distal Femur 3.5 Plating System?

DePuy Synthes VOLT™ Medial Distal Femur 3.5 Plating System is a medical device that received FDA 510(k) clearance on 2026-03-10. It is manufactured by Synthes GmbH. The 510(k) number is K254093.

When was DePuy Synthes VOLT™ Medial Distal Femur 3.5 Plating System approved by the FDA?

DePuy Synthes VOLT™ Medial Distal Femur 3.5 Plating System received FDA 510(k) clearance on 2026-03-10, under approval number K254093.

What company makes DePuy Synthes VOLT™ Medial Distal Femur 3.5 Plating System?

DePuy Synthes VOLT™ Medial Distal Femur 3.5 Plating System is manufactured by Synthes GmbH.

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Official Source

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