FDA 510(k)

NOVOS-NAIL肢體延長系統（LLS）

K 號：K163653 · 2017-10-13

決定日期2017-10-13

產品代碼HSB

諮詢委員會或

決定相當於

器材摘要

NOVOS-NAIL Limb Lengthening System (LLS) is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew. It received FDA 510(k) clearance on 2017-10-13 under 510(k) number K163653. The device is classified under product code HSB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the NOVOS-NAIL Limb Lengthening System (LLS)?

NOVOS-NAIL Limb Lengthening System (LLS) is a medical device that received FDA 510(k) clearance on 2017-10-13. The listed applicant is Smith & Nephew. The 510(k) number is K163653.

When did NOVOS-NAIL Limb Lengthening System (LLS) receive FDA 510(k) clearance?

NOVOS-NAIL Limb Lengthening System (LLS) received FDA 510(k) clearance on 2017-10-13, under 510(k) number K163653.

Who is the listed applicant for NOVOS-NAIL Limb Lengthening System (LLS)?

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

What is the FDA product code for NOVOS-NAIL Limb Lengthening System (LLS)?

The FDA product code for NOVOS-NAIL Limb Lengthening System (LLS) is HSB.

其他以 Smith & Nephew 為申請人之記錄

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相關器械（代碼：HSB）

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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