FDA 510(k)

針管式螺釘及螺母

K 號：K211290 · 2021-08-03

決定日期2021-08-03

產品代碼HWC

諮詢委員會或

決定相當於

器材摘要

Cannulated Fasteners and Nuts is the device name listed in this FDA 510(k) record. The listed applicant is OsteoCentric Technologies. It received FDA 510(k) clearance on 2021-08-03 under 510(k) number K211290. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

常見問題

What is the Cannulated Fasteners and Nuts?

Cannulated Fasteners and Nuts is a medical device that received FDA 510(k) clearance on 2021-08-03. The listed applicant is OsteoCentric Technologies. The 510(k) number is K211290.

When did Cannulated Fasteners and Nuts receive FDA 510(k) clearance?

Cannulated Fasteners and Nuts received FDA 510(k) clearance on 2021-08-03, under 510(k) number K211290.

Who is the listed applicant for Cannulated Fasteners and Nuts?

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

What is the FDA product code for Cannulated Fasteners and Nuts?

The FDA product code for Cannulated Fasteners and Nuts is HWC. This falls under the Cardiovascular category.

其他以 OsteoCentric Technologies 為申請人之記錄

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K251913OsteoCentric® UnifiMI® TCS 鋼板系統 K250494OsteoCentric 骨板及螺釘系統 K242691OsteoCentric Technologies 穿刺螺釘及螺母 K230242骨心齒植體系統 K230226Integrity-SI® 結合系統 K230595骨心臟前交叉韁綁固定系統

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相關器械（代碼：HWC）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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