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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 the device name listed in this FDA 510(k) record. The listed applicant is Overture Resurfacing, Inc.. It received FDA 510(k) clearance on 2023-07-07 under 510(k) 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. The listed applicant is Overture Resurfacing, Inc.. The 510(k) number is K231253.

When did Overture Orthopaedics Patellofemoral System receive FDA 510(k) clearance?

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

Who is the listed applicant for Overture Orthopaedics Patellofemoral System?

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

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

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

Other records listing Overture Resurfacing, Inc. as applicant

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.

K221292Uni Knee Resurfacing System

Related Devices (Code: KRR)

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.

K221048Episealer Patellofemoral SystemEpisurf Medical, Inc.K211303Avon Patello-femoral Joint ProsthesisHowmedica Osteonics Corp., Dba Stryker OrthopaedicsK200122MOTO PFJ SystemMedacta International S.A.K181280Patello-Femoral Wave (Kahuna) Arthroplasty SystemArthrosurface, Inc.K160461Arthrex iBalance BiCompartmental Arthroplasty SystemArthrex, Inc.

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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