FDA 510(k)

Full Wedge Lateralized and Augmented Baseplates

N.º K: K240278 · 2024-05-15

Fecha de decisión2024-05-15

Código de productoPHX

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

Full Wedge Lateralized and Augmented Baseplates is the device name listed in this FDA 510(k) record. The listed applicant is Fx Shoulder USA, Inc.. It received FDA 510(k) clearance on 2024-05-15 under 510(k) number K240278. The device is classified under product code PHX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Full Wedge Lateralized and Augmented Baseplates?

Full Wedge Lateralized and Augmented Baseplates is a medical device that received FDA 510(k) clearance on 2024-05-15. The listed applicant is Fx Shoulder USA, Inc.. The 510(k) number is K240278.

When did Full Wedge Lateralized and Augmented Baseplates receive FDA 510(k) clearance?

Full Wedge Lateralized and Augmented Baseplates received FDA 510(k) clearance on 2024-05-15, under 510(k) number K240278.

Who is the listed applicant for Full Wedge Lateralized and Augmented Baseplates?

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

What is the FDA product code for Full Wedge Lateralized and Augmented Baseplates?

The FDA product code for Full Wedge Lateralized and Augmented Baseplates is PHX.

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Otros registros que enlistan a Fx Shoulder USA, Inc. como solicitante

K223801FX V135(TM) Shoulder Prosthesis K222936Humeris® 135 Shoulder System K213117FX V135 Shoulder Prosthesis K210790Lateralized and Augmented Baseplates K201391Easytech® Anatomical Shoulder System K191698TiN Coated Humeral Head

Ver todos los 11 dispositivos →

Dispositivos relacionados (Código: PHX)

K260556Veritas Shoulder SystemRestor3D K261683Augment Off-Axis Instrument SystemZimmer, Inc.K260102Tornier Perform Reversa Glénoide y Tornier Perform Reversa Glénoide Aumentada del Hombro SistemaStryker Corporation (Tornier, Inc.)K261016MSS - Humeral reverse liners extensionMedacta International, SA K253992Veritas Reverse Total Shoulder SystemRestor3D K252404Comprehensive Reverse Shoulder - HA Glenosphere BaseplatesBiomet Orthopedics

Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.