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FDA 510(k)

VERASENSE Knee System

K-Number: K150372 · 2016-04-15

ApplicantOrthosensor, Inc.
Decision Date2016-04-15
Product CodeONN
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

VERASENSE Knee System is a medical device manufactured by Orthosensor, Inc.. It received FDA 510(k) clearance on 2016-04-15 under approval number K150372. 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 VERASENSE Knee System?

VERASENSE Knee System is a medical device that received FDA 510(k) clearance on 2016-04-15. It is manufactured by Orthosensor, Inc.. The 510(k) number is K150372.

When was VERASENSE Knee System approved by the FDA?

VERASENSE Knee System received FDA 510(k) clearance on 2016-04-15, under approval number K150372.

What company makes VERASENSE Knee System?

VERASENSE Knee System is manufactured by Orthosensor, Inc..

What is the FDA product code for VERASENSE Knee System?

The FDA product code for VERASENSE Knee System is ONN.

Other Devices by Orthosensor, Inc.

K180459VERASENSE for Zimmer Biomet Persona K200587VERASENSE for Exactech Equinoxe Size 38 mm, VERASENSE for Exactech Equinoxe Size 42 mm, LinkStation MINI, LinkStation MINI Evaluation Kit, VERASENSE Software Application for Shoulder K200665VERASENSE for Stryker Triathlon 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 Left

Related Devices (Code: ONN)

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. K220830TrueBalance™ Surgical SystemThese Three Medical, LLC

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.

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