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FDA 510(k)

Overture Orthopaedics Patellofemoral System

K-Number: K231253 · 2023-07-07

ApplicantOverture Resurfacing, Inc.
Decision Date2023-07-07
Product CodeKRR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Overture Orthopaedics Patellofemoral System is a medical device manufactured by Overture Resurfacing, Inc.. It received FDA 510(k) clearance on 2023-07-07 under approval number K231253. The device is classified under product code KRR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Overture Orthopaedics Patellofemoral System?

Overture Orthopaedics Patellofemoral System is a medical device that received FDA 510(k) clearance on 2023-07-07. It is manufactured by Overture Resurfacing, Inc.. The 510(k) number is K231253.

When was Overture Orthopaedics Patellofemoral System approved by the FDA?

Overture Orthopaedics Patellofemoral System received FDA 510(k) clearance on 2023-07-07, under approval number K231253.

What company makes Overture Orthopaedics Patellofemoral System?

Overture Orthopaedics Patellofemoral System is manufactured by Overture Resurfacing, Inc..

What is the FDA product code for Overture Orthopaedics Patellofemoral System?

The FDA product code for Overture Orthopaedics Patellofemoral System is KRR.

Related Clinical Trials

NCT05264389 Post-market Clinical Follow-up (PMCF) Study of the Poly-Tape Devices for Medial Patellofemoral Ligament (MPFL) Reconstruction ACTIVE_NOT_RECRUITING NCT05304819 PMCF Study of the AchilloCordPLUS System Implant Set for Acute Achilles Tendon Repair COMPLETED

Other Devices by Overture Resurfacing, Inc.

K221292Uni Knee Resurfacing System

Related Devices (Code: KRR)

K160461Arthrex iBalance BiCompartmental Arthroplasty SystemArthrex, Inc. K181280Patello-Femoral Wave (Kahuna) Arthroplasty SystemArthrosurface, Inc. K200122MOTO PFJ SystemMedacta International S.A. K211303Avon Patello-femoral Joint ProsthesisHowmedica Osteonics Corp., Dba Stryker Orthopaedics K221048Episealer Patellofemoral SystemEpisurf Medical, Inc.

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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