FDA 510(k)

GPC品牌後路、非椎管內椎板螺釘脊柱系統

K 號：K163096 · 2017-03-31

決定日期2017-03-31

產品代碼NKB

諮詢委員會或

決定相當於

器材摘要

GPC BRAND Posterior, Non cervical Pedicle Screw Spinal System is the device name listed in this FDA 510(k) record. The listed applicant is Gpc Medical Limited. It received FDA 510(k) clearance on 2017-03-31 under 510(k) number K163096. 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 GPC BRAND Posterior, Non cervical Pedicle Screw Spinal System?

GPC BRAND Posterior, Non cervical Pedicle Screw Spinal System is a medical device that received FDA 510(k) clearance on 2017-03-31. The listed applicant is Gpc Medical Limited. The 510(k) number is K163096.

When did GPC BRAND Posterior, Non cervical Pedicle Screw Spinal System receive FDA 510(k) clearance?

GPC BRAND Posterior, Non cervical Pedicle Screw Spinal System received FDA 510(k) clearance on 2017-03-31, under 510(k) number K163096.

Who is the listed applicant for GPC BRAND Posterior, Non cervical Pedicle Screw Spinal System?

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

What is the FDA product code for GPC BRAND Posterior, Non cervical Pedicle Screw Spinal System?

The FDA product code for GPC BRAND Posterior, Non cervical Pedicle Screw Spinal System is NKB.

其他以 Gpc Medical Limited 為申請人之記錄

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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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