FDA 510(k)

GREENS品牌後路、非椎間孔椎板螺釘脊柱系統

K 號：K230325 · 2024-10-10

決定日期2024-10-10

產品代碼NKB

諮詢委員會或

決定相當於

器材摘要

GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal System is the device name listed in this FDA 510(k) record. The listed applicant is Greens Surgicals Pvt. , Ltd.. It received FDA 510(k) clearance on 2024-10-10 under 510(k) number K230325. 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 GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal System?

GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal System is a medical device that received FDA 510(k) clearance on 2024-10-10. The listed applicant is Greens Surgicals Pvt. , Ltd.. The 510(k) number is K230325.

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

GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal System received FDA 510(k) clearance on 2024-10-10, under 510(k) number K230325.

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

The FDA 510(k) record lists Greens Surgicals Pvt. , Ltd. as the applicant. This does not by itself establish the device manufacturer.

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

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

其他以 Greens Surgicals Pvt. , Ltd. 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。

K163383GREENS 品牌鎖定骨板及螺釘骨合板釘系統，GREENS 品牌DHS/動態恥骨板釘系統

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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