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FDA 510(k)

iBalance UKA Tibial Tray Implant

K-Number: K200433 · 2020-03-17

ApplicantArthrex, Inc.
Decision Date2020-03-17
Product CodeHSX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

iBalance UKA Tibial Tray Implant is a medical device manufactured by Arthrex, Inc.. It received FDA 510(k) clearance on 2020-03-17 under approval number K200433. The device is classified under product code HSX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the iBalance UKA Tibial Tray Implant?

iBalance UKA Tibial Tray Implant is a medical device that received FDA 510(k) clearance on 2020-03-17. It is manufactured by Arthrex, Inc.. The 510(k) number is K200433.

When was iBalance UKA Tibial Tray Implant approved by the FDA?

iBalance UKA Tibial Tray Implant received FDA 510(k) clearance on 2020-03-17, under approval number K200433.

What company makes iBalance UKA Tibial Tray Implant?

iBalance UKA Tibial Tray Implant is manufactured by Arthrex, Inc..

What is the FDA product code for iBalance UKA Tibial Tray Implant?

The FDA product code for iBalance UKA Tibial Tray Implant is HSX.

Related Clinical Trials

NCT06019832 Analysis of Varus Collapse in Obese Patients With Stem and Non-Stem Tibial Components Following Primary Total Knee Arthroplasty ACTIVE_NOT_RECRUITING NCT07544264 Evaluation of 5-year Survival and Clinical Outcomes in Patients Undergoing Total Knee Arthroplasty With a Polyethylene Tibial Component NOT_YET_RECRUITING NCT06636136 Transtibial Osseointegration RECRUITING

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Related Devices (Code: HSX)

K161060Arthrex iBalance UKA System Vitamin E Tibial BearingArthrex, Inc. K161592Persona Partial Knee SystemBiomet, Inc. K160738ZUK Select Knee SystemSmith & Nephew, Inc. K172650Materialise PKA Guide SystemMaterialise NV K170344Tahoe Uni Knee SystemConsensus Orthopedics, Inc. K161741GMK UNIMedacta International S.A.

Official Source

View on FDA Database →

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

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