FDA 510(k)

Catalyst R1 Reverse Shoulder System

N.º K: K211991 · 2021-07-28

Fecha de decisión2021-07-28

Código de productoPHX

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

Catalyst R1 Reverse Shoulder System is the device name listed in this FDA 510(k) record. The listed applicant is Catalyst Orthoscience, Inc.. It received FDA 510(k) clearance on 2021-07-28 under 510(k) number K211991. 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 Catalyst R1 Reverse Shoulder System?

Catalyst R1 Reverse Shoulder System is a medical device that received FDA 510(k) clearance on 2021-07-28. The listed applicant is Catalyst Orthoscience, Inc.. The 510(k) number is K211991.

When did Catalyst R1 Reverse Shoulder System receive FDA 510(k) clearance?

Catalyst R1 Reverse Shoulder System received FDA 510(k) clearance on 2021-07-28, under 510(k) number K211991.

Who is the listed applicant for Catalyst R1 Reverse Shoulder System?

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

What is the FDA product code for Catalyst R1 Reverse Shoulder System?

The FDA product code for Catalyst R1 Reverse Shoulder System is PHX.

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Otros registros que enlistan a Catalyst Orthoscience, Inc. como solicitante

K252418Catalyst F1x Shoulder System K234105Catalyst F1x Shoulder System K232583Catalyst R1 Reverse Shoulder System K223655Catalyst R1 Reverse Shoulder System K222317Catalyst EA Convertible Stemmed Shoulder K213349Catalyst R1 Reverse Shoulder System

Ver todos los 12 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.