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FDA 510(k)

內嵌式骨固定系統

K 號:K171831 · 2017-10-26

決定日期2017-10-26
產品代碼DZL
諮詢委員會DE
決定相當於

器材摘要

Intra-Lock Bone Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is Intra-Lock International, Inc.. It received FDA 510(k) clearance on 2017-10-26 under 510(k) number K171831. The device is classified under product code DZL. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Intra-Lock Bone Fixation System?

Intra-Lock Bone Fixation System is a medical device that received FDA 510(k) clearance on 2017-10-26. The listed applicant is Intra-Lock International, Inc.. The 510(k) number is K171831.

When did Intra-Lock Bone Fixation System receive FDA 510(k) clearance?

Intra-Lock Bone Fixation System received FDA 510(k) clearance on 2017-10-26, under 510(k) number K171831.

Who is the listed applicant for Intra-Lock Bone Fixation System?

The FDA 510(k) record lists Intra-Lock International, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Intra-Lock Bone Fixation System?

The FDA product code for Intra-Lock Bone Fixation System is DZL.

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相關器械(代碼:DZL)

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。

官方來源

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