FDA 510(k)

Remplir (ON-152, 15 x 20 mm); Remplir (ON-203, 20 x 30 mm); Remplir (ON-304, 30 x 40 mm); Remplir (ON-405, 40 x 50 mm)

N.º K: K243889 · 2025-04-02

Fecha de decisión2025-04-02

Código de productoJXI

Comité asesorNE

DecisiónSubstantially Equivalent

Resumen del dispositivo

Remplir (ON-152, 15 x 20 mm); Remplir (ON-203, 20 x 30 mm); Remplir (ON-304, 30 x 40 mm); Remplir (ON-405, 40 x 50 mm) is the device name listed in this FDA 510(k) record. The listed applicant is Orthocell, Ltd.. It received FDA 510(k) clearance on 2025-04-02 under 510(k) number K243889. The device is classified under product code JXI. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Remplir (ON-152, 15 x 20 mm); Remplir (ON-203, 20 x 30 mm); Remplir (ON-304, 30 x 40 mm); Remplir (ON-405, 40 x 50 mm)?

Remplir (ON-152, 15 x 20 mm); Remplir (ON-203, 20 x 30 mm); Remplir (ON-304, 30 x 40 mm); Remplir (ON-405, 40 x 50 mm) is a medical device that received FDA 510(k) clearance on 2025-04-02. The listed applicant is Orthocell, Ltd.. The 510(k) number is K243889.

When did Remplir (ON-152, 15 x 20 mm); Remplir (ON-203, 20 x 30 mm); Remplir (ON-304, 30 x 40 mm); Remplir (ON-405, 40 x 50 mm) receive FDA 510(k) clearance?

Remplir (ON-152, 15 x 20 mm); Remplir (ON-203, 20 x 30 mm); Remplir (ON-304, 30 x 40 mm); Remplir (ON-405, 40 x 50 mm) received FDA 510(k) clearance on 2025-04-02, under 510(k) number K243889.

Who is the listed applicant for Remplir (ON-152, 15 x 20 mm); Remplir (ON-203, 20 x 30 mm); Remplir (ON-304, 30 x 40 mm); Remplir (ON-405, 40 x 50 mm)?

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

What is the FDA product code for Remplir (ON-152, 15 x 20 mm); Remplir (ON-203, 20 x 30 mm); Remplir (ON-304, 30 x 40 mm); Remplir (ON-405, 40 x 50 mm)?

The FDA product code for Remplir (ON-152, 15 x 20 mm); Remplir (ON-203, 20 x 30 mm); Remplir (ON-304, 30 x 40 mm); Remplir (ON-405, 40 x 50 mm) is JXI.

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Fuente oficial

Ver en la base de datos de la FDA →

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