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FDA 510(k)

Episealer Patellofemoral System

K-Number: K221048 · 2022-12-23

ApplicantEpisurf Medical, Inc.
Decision Date2022-12-23
Product CodeKRR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Episealer Patellofemoral System is the device name listed in this FDA 510(k) record. The listed applicant is Episurf Medical, Inc.. It received FDA 510(k) clearance on 2022-12-23 under 510(k) number K221048. 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 Episealer Patellofemoral System?

Episealer Patellofemoral System is a medical device that received FDA 510(k) clearance on 2022-12-23. The listed applicant is Episurf Medical, Inc.. The 510(k) number is K221048.

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

Episealer Patellofemoral System received FDA 510(k) clearance on 2022-12-23, under 510(k) number K221048.

Who is the listed applicant for Episealer Patellofemoral System?

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

What is the FDA product code for Episealer Patellofemoral System?

The FDA product code for Episealer Patellofemoral System is KRR.

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.

K231253Overture Orthopaedics Patellofemoral SystemOverture Resurfacing, 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

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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