FDA 510(k)

TREND II脊椎固定系統- STEP 系列

K 號：K180226 · 2018-07-25

決定日期2018-07-25

產品代碼NKB

諮詢委員會或

決定相當於

器材摘要

TREND II Spinal Fixation System- STEP Series is the device name listed in this FDA 510(k) record. The listed applicant is Paonan Biotech Co., Ltd.. It received FDA 510(k) clearance on 2018-07-25 under 510(k) number K180226. 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 TREND II Spinal Fixation System- STEP Series?

TREND II Spinal Fixation System- STEP Series is a medical device that received FDA 510(k) clearance on 2018-07-25. The listed applicant is Paonan Biotech Co., Ltd.. The 510(k) number is K180226.

When did TREND II Spinal Fixation System- STEP Series receive FDA 510(k) clearance?

TREND II Spinal Fixation System- STEP Series received FDA 510(k) clearance on 2018-07-25, under 510(k) number K180226.

Who is the listed applicant for TREND II Spinal Fixation System- STEP Series?

The FDA 510(k) record lists Paonan Biotech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TREND II Spinal Fixation System- STEP Series?

The FDA product code for TREND II Spinal Fixation System- STEP Series is NKB.

其他以 Paonan Biotech Co., Ltd. 為申請人之記錄

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相關器械（代碼：NKB）

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