FDA 510(k)

Persona® Revision Knee System (Persona Revision SoluTion™ Femoral Components)

K-Nummer: K243724 · 2025-03-06

Entscheidungsdatum2025-03-06

ProduktcodeJWH

BeratungsausschussOR

EntscheidungSubstantially Equivalent

Produktübersicht

Persona® Revision Knee System (Persona Revision SoluTion™ Femoral Components) is the device name listed in this FDA 510(k) record. The listed applicant is Zimmer, Inc.. It received FDA 510(k) clearance on 2025-03-06 under 510(k) number K243724. The device is classified under product code JWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Häufig gestellte Fragen

What is the Persona® Revision Knee System (Persona Revision SoluTion™ Femoral Components)?

Persona® Revision Knee System (Persona Revision SoluTion™ Femoral Components) is a medical device that received FDA 510(k) clearance on 2025-03-06. The listed applicant is Zimmer, Inc.. The 510(k) number is K243724.

When did Persona® Revision Knee System (Persona Revision SoluTion™ Femoral Components) receive FDA 510(k) clearance?

Persona® Revision Knee System (Persona Revision SoluTion™ Femoral Components) received FDA 510(k) clearance on 2025-03-06, under 510(k) number K243724.

Who is the listed applicant for Persona® Revision Knee System (Persona Revision SoluTion™ Femoral Components)?

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

What is the FDA product code for Persona® Revision Knee System (Persona Revision SoluTion™ Femoral Components)?

The FDA product code for Persona® Revision Knee System (Persona Revision SoluTion™ Femoral Components) is JWH.

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Weitere Einträge mit Zimmer, Inc. als Antragsteller

K262955OsseoFit Stemless Shoulder System K261683Augment Off-Axis Instrument System K260831Z1 Hip System K251840Zimmer® Persona® Personalized Knee System K260182Avenir® Müller Stem; Avenir Complete™ Hip System K253592Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral Trays, Comprehensive Reverse Humeral Trays, Comprehensive Reverse 32mm Glenospheres and Adapter)

Alle 61 Geräte anzeigen →

Verwandte Geräte (Code: JWH)

K262057GMK ExtensionMedacta International SA K260063GSPE SpacerThe General Hospital Corporation, d/b/a Massachusetts K262293EVOLUTION MPX™ Total Knee SystemSuzhou Microport Orthorecon Co., Ltd.K262341b-ONE® Mobio™ Total Knee System Revision Cemented Tibial Augments, Stem Extensions and Press-Fit Stem ExtensionsB-One Ortho, Corp.K262130ATTUNE Revision KniegelenkssystemDepuy Orthopaedics, Inc.K253961SK Knee SystemJust Medical Devices (Tianjin) Co., Ltd.

Offizielle Quelle

In der FDA-Datenbank anzeigen →

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