FDA 510(k)

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

K-Number: K254054 · 2026-03-02

Decision Date2026-03-02

Product CodeHRS

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

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. It is manufactured by Synthes GmbH. The 510(k) number is K254054.

When was VOLT Ankle Trauma 2.7/3.5 Plating System; VOLT Calcaneus 2.7 Plating System approved by the FDA?

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 approval number K254054.

What company makes 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 manufactured by Synthes GmbH.

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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Related Devices (Code: HRS)

K163086VLP MINI-MOD 2.0mm Column PlatesSmith & Nephew, Inc. K162829Medline UNITE® Ankle Fracture Plating SystemMedline Industries, Inc. K162974Biomet Microfixation RibFix Blu Thoracic Fixation SystemBiomet Microfixation K163007Biomet Microfixation SternaLock 360 Sternal Closure SystemBiomet Microfixation K161696aap LOQTEQ® Distal Lateral Humerus Plate 2.7/3.5Aap Implantate AG K161747LOQTEQ® VA Distal Tibia Plate System: LOQTEQ® VA Distal Medial Tibia Plate 3.5; LOQTEQ® VA Distal Anterolateral Tibia Plate 3.5; LOQTEQ® VA Distal Fibula Plate 2.7/3.5Aap Implantate AG

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.