Mechanical performance of cervical intervertebral body fusion devices: A systematic analysis of data submitted to the Food and Drug Administration.
PMID : 28256243 ·
J, o, n, a, t, h, a, n, , H, , P, e, c, k, ;, , D, a, v, i, d, , C, , S, i, n, g, ;, , S, r, i, n, i, d, h, i, , N, a, g, a, r, a, j, a, ;, , D, e, e, p, a, , G, , P, e, c, k, ;, , J, e, f, f, r, e, y, , C, , L, o, t, z, ;, , A, n, t, o, n, , E, , D, m, i, t, r, i, e, v
Publicité
Résumé
Cervical intervertebral body fusion devices (IBFDs) are utilized to provide stability while fusion occurs in patients with cervical pathology. For a manufacturer to market a new cervical IBFD in the United States, substantial equivalence to a cervical IBFD previously cleared by FDA must be established through the 510(k) regulatory pathway. Mechanical performance data are typically provided as part of the 510(k) process for IBFDs. We reviewed all Traditional 510(k) submissions for cervical IBFDs
Publicité
Source officielle
Voir sur PubMed →Données issues de PubMed / NCBI. Pour le texte intégral et les informations les plus récentes, consultez toujours la notice officielle.