FDA 510(k)

Permatage Flowable, Settable Bone Paste

Número K: K253732 · 2026-03-13

Data da decisão2026-03-13

Código do produtoGXP

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Permatage Flowable, Settable Bone Paste is the device name listed in this FDA 510(k) record. The listed applicant is Orthocon, Inc.. It received FDA 510(k) clearance on 2026-03-13 under 510(k) number K253732. The device is classified under product code GXP. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Permatage Flowable, Settable Bone Paste?

Permatage Flowable, Settable Bone Paste is a medical device that received FDA 510(k) clearance on 2026-03-13. The listed applicant is Orthocon, Inc.. The 510(k) number is K253732.

When did Permatage Flowable, Settable Bone Paste receive FDA 510(k) clearance?

Permatage Flowable, Settable Bone Paste received FDA 510(k) clearance on 2026-03-13, under 510(k) number K253732.

Who is the listed applicant for Permatage Flowable, Settable Bone Paste?

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 Permatage Flowable, Settable Bone Paste?

The FDA product code for Permatage Flowable, Settable Bone Paste is GXP.

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Outros registros que listam Orthocon, Inc. como candidato(a)

K262769Permatage XT Settable Nonabsorbable Hemostatic Bone Putty (OS-PER-1001XT)K261265Permatage XT Settable Bone Putty K261439Permatage Flowable, Settable Hemostatic Bone Paste K253447Montage Flowable Settable, Resorbable Bone Paste (Burr Hole Cover)K253854Cimento Cranial MONTAGE XT K243526MONTAGE Settable, Resorbable Bone Putty MONTAGE-QS Settable, Resorbable Bone Putty MONTAGE Flowable Settable, Resorbable Bone Paste MONTAGE-XT Settable, Resorbable Hemostatic Bone Putty

Ver todos os 25 dispositivos →

Dispositivos Relacionados (Código: GXP)

K251959TnR Cranial ImplantT&R BIOFAB CO., Ltd.K261265Permatage XT Settable Bone PuttyOrthocon, Inc.K253854Cimento Cranial MONTAGE XTOrthocon, Inc.K241027Permatage Settable Bone PuttyOrthocon, Inc.K232771Montage Flowable Settable, Resorbable Bone PasteOrthocon, Inc.K231475MONTAGE-QS Settable, Resorbable Bone PuttyOrthocon, Inc.

Fonte oficial

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