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FDA PMA

人工關節,膝蓋,股骨-髌骨,單間室,半限制性,金屬/聚合物,活動軸承

PMA 核准號:P010014 · 2026-09-01

決定日期2026-09-01
PMA 編號P010014
產品代碼NRA
器械分類3 類
醫療專科U
諮詢委員會或

器材摘要

Prosthesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing is the device name listed in this FDA 510(k) record. The listed applicant is Biomet Manufacturing Corp. It received FDA 510(k) clearance on 2026-09-01. The device is classified under product code NRA. It was reviewed by the OR advisory panel.

常見問題

What is the Prosthesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing?

Prosthesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing is a medical device that received FDA 510(k) clearance on 2026-09-01. The listed applicant is Biomet Manufacturing Corp.

When did Prosthesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing receive FDA 510(k) clearance?

The clearance date for Prosthesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing can be found in the official FDA records.

誰是Prosthesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing的登記申請人?

The FDA 510(k) record lists Biomet Manufacturing Corp as the applicant. This does not by itself establish the device manufacturer.

FDA產品代碼為Prosthesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing是什麼?

FDA產品代碼對於人工關節、膝蓋、股骨-髌骨,單間室,半限制性,金屬/聚合物,活動承重為NRA。

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官方來源

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