FDA 510(k)

EXPEDIUM®脊椎系統；EXPEDIUM VERSE®脊椎系統

K 號：K200245 · 2020-04-24

決定日期2020-04-24

產品代碼NKB

諮詢委員會或

決定相當於

器材摘要

EXPEDIUM® Spine System; EXPEDIUM VERSE® Spine System is the device name listed in this FDA 510(k) record. The listed applicant is Medos International Sàrl. It received FDA 510(k) clearance on 2020-04-24 under 510(k) number K200245. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the EXPEDIUM® Spine System; EXPEDIUM VERSE® Spine System?

EXPEDIUM® Spine System; EXPEDIUM VERSE® Spine System is a medical device that received FDA 510(k) clearance on 2020-04-24. The listed applicant is Medos International Sàrl. The 510(k) number is K200245.

When did EXPEDIUM® Spine System; EXPEDIUM VERSE® Spine System receive FDA 510(k) clearance?

EXPEDIUM® Spine System; EXPEDIUM VERSE® Spine System received FDA 510(k) clearance on 2020-04-24, under 510(k) number K200245.

Who is the listed applicant for EXPEDIUM® Spine System; EXPEDIUM VERSE® Spine System?

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

What is the FDA product code for EXPEDIUM® Spine System; EXPEDIUM VERSE® Spine System?

The FDA product code for EXPEDIUM® Spine System; EXPEDIUM VERSE® Spine System is NKB.

其他以 Medos International Sàrl 為申請人之記錄

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。

K231527TriALTIS 選向啟用儀器 K223688CONDUIT™ 横向腰椎椎間融合籠，CONDUIT™ 工具 K160879CONFIDENCE™ 高濃度脊椎水泥，VIPER® 及 EXPEDIUM® 穿孔螺釘系統

相關器械（代碼：NKB）

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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官方來源

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