Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 a medical device manufactured by Episurf Medical, Inc.. It received FDA 510(k) clearance on 2022-12-23 under approval 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. It is manufactured by Episurf Medical, Inc.. The 510(k) number is K221048.

When was Episealer Patellofemoral System approved by the FDA?

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

What company makes Episealer Patellofemoral System?

Episealer Patellofemoral System is manufactured by Episurf Medical, Inc..

What is the FDA product code for Episealer Patellofemoral System?

The FDA product code for Episealer Patellofemoral System is KRR.

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 K231253Overture Orthopaedics Patellofemoral SystemOverture Resurfacing, 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.

↑