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FDA PMA

填充物,重组人骨形态生成蛋白,含金属支架的胶原蛋白支架,骨诱导

PMA 核准號:P000058 · 2026-08-26

決定日期2026-08-26
PMA 編號P000058
產品代碼NEK
器械分類3 類
醫療專科U
諮詢委員會或

器材摘要

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.

常見問題

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.

誰是填充劑,重组人骨形态發育蛋白,含金屬假體的膠原支架,骨導引的登記申請人?

FDA 510(k) 記錄將美敦力索法莫丹克美國,股份有限公司列為申請人。這並不單獨確立設備製造商。

FDA產品代碼是什麼?針對填充劑、重组人骨形态發育蛋白、含金屬支架的膠原支架,以及骨導引的產品?

FDA產品代碼為Filler,重组人骨形态發育蛋白,含金屬假體的膠原支架,骨導引為NEK。

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官方來源

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