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PMA de la FDA

Filler, recombinant human bone morphogenetic protein, collagen scaffold with metal prosthesis, osteoinduction

Número de PMA: P000058 · 2026-08-26

SolicitanteMedtronic Sofamor Danek USA, Inc.
Fecha de decisión2026-08-26
Número PMAP000058
Código de productoNEK
Clase del dispositivoClase 3
Especialidad médicaU
Comité asesorOR

Resumen del dispositivo

Filler, recombinant human bone morphogenetic protein, collagen scaffold with metal prosthesis, osteoinduction is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Sofamor Danek USA, Inc.. It received FDA 510(k) clearance on 2026-08-26. The device is classified under product code NEK. It was reviewed by the OR advisory panel.

Preguntas frecuentes

What is the Filler, recombinant human bone morphogenetic protein, collagen scaffold with metal prosthesis, osteoinduction?

Filler, recombinant human bone morphogenetic protein, collagen scaffold with metal prosthesis, osteoinduction is a medical device that received FDA 510(k) clearance on 2026-08-26. The listed applicant is Medtronic Sofamor Danek USA, Inc..

When did Filler, recombinant human bone morphogenetic protein, collagen scaffold with metal prosthesis, osteoinduction receive FDA 510(k) clearance?

The clearance date for Filler, recombinant human bone morphogenetic protein, collagen scaffold with metal prosthesis, osteoinduction can be found in the official FDA records.

Who is the listed applicant for Filler, recombinant human bone morphogenetic protein, collagen scaffold with metal prosthesis, osteoinduction?

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

What is the FDA product code for Filler, recombinant human bone morphogenetic protein, collagen scaffold with metal prosthesis, osteoinduction?

The FDA product code for Filler, recombinant human bone morphogenetic protein, collagen scaffold with metal prosthesis, osteoinduction is NEK.

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Fuente oficial

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