FDA 510(k)

Montage Flowable Settable, Resorbable Bone Paste (Burr Hole Cover)

N.º K: K253447 · 2026-03-16

Fecha de decisión2026-03-16

Código de productoGXR

Comité asesorNE

DecisiónSubstantially Equivalent

Resumen del dispositivo

Montage Flowable Settable, Resorbable Bone Paste (Burr Hole Cover) is the device name listed in this FDA 510(k) record. The listed applicant is Orthocon, Inc.. It received FDA 510(k) clearance on 2026-03-16 under 510(k) number K253447. The device is classified under product code GXR. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Montage Flowable Settable, Resorbable Bone Paste (Burr Hole Cover)?

Montage Flowable Settable, Resorbable Bone Paste (Burr Hole Cover) is a medical device that received FDA 510(k) clearance on 2026-03-16. The listed applicant is Orthocon, Inc.. The 510(k) number is K253447.

When did Montage Flowable Settable, Resorbable Bone Paste (Burr Hole Cover) receive FDA 510(k) clearance?

Montage Flowable Settable, Resorbable Bone Paste (Burr Hole Cover) received FDA 510(k) clearance on 2026-03-16, under 510(k) number K253447.

Who is the listed applicant for Montage Flowable Settable, Resorbable Bone Paste (Burr Hole Cover)?

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

What is the FDA product code for Montage Flowable Settable, Resorbable Bone Paste (Burr Hole Cover)?

The FDA product code for Montage Flowable Settable, Resorbable Bone Paste (Burr Hole Cover) is GXR.

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Otros registros que enlistan a Orthocon, Inc. como solicitante

K262769Permatage XT Settable Nonabsorbable Hemostatic Bone Putty (OS-PER-1001XT)K261265Permatage XT Settable Bone Putty K261439Permatage Flowable, Settable Hemostatic Bone Paste K253732Permatage Flowable, Settable Bone Paste K253854MONTAGE XT Cranial Cement K243526MONTAGE Settable, Resorbable Bone Putty MONTAGE-QS Settable, Resorbable Bone Putty MONTAGE Flowable Settable, Resorbable Bone Paste MONTAGE-XT Settable, Resorbable Hemostatic Bone Putty

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Fuente oficial

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