Aviso: Este site agrega dados públicos oficiais da FDA, ClinicalTrials.gov, PubMed e SEC EDGAR apenas para referência geral. Não constitui aconselhamento médico, diagnóstico, recomendação de tratamento ou aconselhamento de investimento.

FDA PMA

Filler, recombinant human bone morphogenetic protein, collagen scaffold, osteoinduction

Número do PMA: P000054 · 2026-08-26

RequerenteMedtronic Sofamor Danek USA, Inc.
Data da decisão2026-08-26
Número PMAP000054
Código do produtoMPW
Classe do DispositivoClasse 3
Especialidade MédicaU
Comité consultivoOR

Resumo do dispositivo

Filler, recombinant human bone morphogenetic protein, collagen scaffold, 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 MPW. It was reviewed by the OR advisory panel.

Perguntas frequentes

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

Filler, recombinant human bone morphogenetic protein, collagen scaffold, 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, osteoinduction receive FDA 510(k) clearance?

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

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

The FDA product code for Filler, recombinant human bone morphogenetic protein, collagen scaffold, osteoinduction is MPW.

Ensaios clínicos relacionados

Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Fonte oficial

Ver na base de dados da FDA →

Dados provenientes da FDA Open API. Para informações mais recentes e oficiais, consulte sempre o registro oficial.

↑