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FDA-PMA

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

PMA-Nummer: P000058 · 2026-08-26

AntragstellerMedtronic Sofamor Danek USA, Inc.
Entscheidungsdatum2026-08-26
PMA-NummerP000058
ProduktcodeNEK
GeräteklasseKlasse 3
Medizinische FachrichtungU
BeratungsausschussOR

Produktübersicht

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.

Häufig gestellte Fragen

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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