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FDA 510(k)

VERASENSE for Stryker Triathlon

K-Number: K200665 · 2020-04-12

ApplicantOrthosensor, Inc.
Decision Date2020-04-12
Product CodeONN
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

VERASENSE for Stryker Triathlon is a medical device manufactured by Orthosensor, Inc.. It received FDA 510(k) clearance on 2020-04-12 under approval number K200665. 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 for Stryker Triathlon?

VERASENSE for Stryker Triathlon is a medical device that received FDA 510(k) clearance on 2020-04-12. It is manufactured by Orthosensor, Inc.. The 510(k) number is K200665.

When was VERASENSE for Stryker Triathlon approved by the FDA?

VERASENSE for Stryker Triathlon received FDA 510(k) clearance on 2020-04-12, under approval number K200665.

What company makes VERASENSE for Stryker Triathlon?

VERASENSE for Stryker Triathlon is manufactured by Orthosensor, Inc..

What is the FDA product code for VERASENSE for Stryker Triathlon?

The FDA product code for VERASENSE for Stryker Triathlon is ONN.

Other Devices by Orthosensor, Inc.

K150372VERASENSE Knee System 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 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)

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. 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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