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FDA 510(k)

XO1 Knee Balancing System

K-Number: K162237 · 2017-04-25

ApplicantXpandortho, Inc.
Decision Date2017-04-25
Product CodeONN
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

XO1 Knee Balancing System is the device name listed in this FDA 510(k) record. The listed applicant is Xpandortho, Inc.. It received FDA 510(k) clearance on 2017-04-25 under 510(k) number K162237. 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 XO1 Knee Balancing System?

XO1 Knee Balancing System is a medical device that received FDA 510(k) clearance on 2017-04-25. The listed applicant is Xpandortho, Inc.. The 510(k) number is K162237.

When did XO1 Knee Balancing System receive FDA 510(k) clearance?

XO1 Knee Balancing System received FDA 510(k) clearance on 2017-04-25, under 510(k) number K162237.

Who is the listed applicant for XO1 Knee Balancing System?

The FDA 510(k) record lists Xpandortho, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for XO1 Knee Balancing System?

The FDA product code for XO1 Knee Balancing System is ONN.

Related Devices (Code: ONN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262253Lantern Knee Navigation Unit (406000-03);Lantern Hip Navigation Unit (502000-03)Orthalign, Inc.K253507Packaged Assembly, Reusable Navigation Unit; Lantern ASC, Smart Pack kit, KneeOrthalign, Inc.K252524Quadsense (Quadsense and Quadsense Pro)Eventum Orthopaedics, Ltd.K241298QUADSENSEEventum Orthopaedics, Ltd.K242616Lantern® HipOrthalign, 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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