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FDA 510(k)

Uni Knee Resurfacing System

K-Number: K221292 · 2023-03-10

ApplicantOverture Resurfacing, Inc.
Decision Date2023-03-10
Product CodeHSX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Uni Knee Resurfacing System is a medical device manufactured by Overture Resurfacing, Inc.. It received FDA 510(k) clearance on 2023-03-10 under approval number K221292. 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 Uni Knee Resurfacing System?

Uni Knee Resurfacing System is a medical device that received FDA 510(k) clearance on 2023-03-10. It is manufactured by Overture Resurfacing, Inc.. The 510(k) number is K221292.

When was Uni Knee Resurfacing System approved by the FDA?

Uni Knee Resurfacing System received FDA 510(k) clearance on 2023-03-10, under approval number K221292.

What company makes Uni Knee Resurfacing System?

Uni Knee Resurfacing System is manufactured by Overture Resurfacing, Inc..

What is the FDA product code for Uni Knee Resurfacing System?

The FDA product code for Uni Knee Resurfacing System is HSX.

Related Clinical Trials

NCT06792539 Evaluate the Safety and Effectiveness of the Polymotion Hip Resurfacing (PHR) System Compared to Total Hip Arthroplasty ACTIVE_NOT_RECRUITING NCT06368700 The HYALEX Pivotal Study RECRUITING NCT00611585 A Safety and Efficacy Study of the Birmingham Hip Resurfacing System COMPLETED

Other Devices by Overture Resurfacing, Inc.

K231253Overture Orthopaedics Patellofemoral System

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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