FDA 510(k)

QUADSENSE

K-Number: K241298 · 2024-10-04

Decision Date2024-10-04

Product CodeONN

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

QUADSENSE is a medical device manufactured by Eventum Orthopaedics, Ltd.. It received FDA 510(k) clearance on 2024-10-04 under approval number K241298. The device is classified under product code ONN. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QUADSENSE?

QUADSENSE is a medical device that received FDA 510(k) clearance on 2024-10-04. It is manufactured by Eventum Orthopaedics, Ltd.. The 510(k) number is K241298.

When was QUADSENSE approved by the FDA?

QUADSENSE received FDA 510(k) clearance on 2024-10-04, under approval number K241298.

What company makes QUADSENSE?

QUADSENSE is manufactured by Eventum Orthopaedics, Ltd..

What is the FDA product code for QUADSENSE?

The FDA product code for QUADSENSE is ONN.

Other Devices by Eventum Orthopaedics, Ltd.

K252524Quadsense (Quadsense and Quadsense Pro)

Related Devices (Code: ONN)

K150372VERASENSE Knee SystemOrthosensor, Inc. K162237XO1 Knee Balancing SystemXpandortho, Inc. K180459VERASENSE for Zimmer Biomet PersonaOrthosensor, Inc. K200587VERASENSE for Exactech Equinoxe Size 38 mm, VERASENSE for Exactech Equinoxe Size 42 mm, LinkStation MINI, LinkStation MINI Evaluation Kit, VERASENSE Software Application for ShoulderOrthosensor, Inc. K200665VERASENSE for Stryker TriathlonOrthosensor, Inc. K193580VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Left, VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Right, VERASENSE for Zimmer Biomet Persona CR E-F/3-11 Left, VERASENSE for Zimmer Biomet Persona CR E-F/3-11 Right, VERASENSE for Zimmer Biomet Persona CR G-H/7-12 LeftOrthosensor, Inc.

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.