PubMed

Mechanical performance of cervical intervertebral body fusion devices: A systematic analysis of data submitted to the Food and Drug Administration.

PMID: 28256243 · 2017-02-01

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

ЖурналJournal of biomechanics

Год2017-02-01

PMID28256243

Аннотация

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

Официальный источник

Открыть в PubMed →

Данные получены из PubMed / NCBI. Полный текст и наиболее актуальную информацию всегда смотрите в официальной записи.