FDA 510(k)

VOLT Proximal Humerus 3.5 Plating System

K-Number: K233994 · 2024-07-26

Decision Date2024-07-26

Product CodeHRS

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

VOLT Proximal Humerus 3.5 Plating System is a medical device manufactured by Synthes GmbH. It received FDA 510(k) clearance on 2024-07-26 under approval number K233994. 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 Proximal Humerus 3.5 Plating System?

VOLT Proximal Humerus 3.5 Plating System is a medical device that received FDA 510(k) clearance on 2024-07-26. It is manufactured by Synthes GmbH. The 510(k) number is K233994.

When was VOLT Proximal Humerus 3.5 Plating System approved by the FDA?

VOLT Proximal Humerus 3.5 Plating System received FDA 510(k) clearance on 2024-07-26, under approval number K233994.

What company makes VOLT Proximal Humerus 3.5 Plating System?

VOLT Proximal Humerus 3.5 Plating System is manufactured by Synthes GmbH.

What is the FDA product code for VOLT Proximal Humerus 3.5 Plating System?

The FDA product code for VOLT Proximal Humerus 3.5 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

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