FDA 510(k)

GREENS BRAND 後方、非脊椎骨棘突スクリュー脊椎システム

K番号: K230325 · 2024-10-10

決定日2024-10-10

製品コードNKB

諮問委員会医薬品機器規制テキストの翻訳は以下の通りです。 [原文] OR [翻訳] OR 注：原文が具体的な内容を含んでいないため、翻訳は単なる「OR」のままです。

決定大幅同等

医療機器の概要

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.

よくある質問

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.

申請者としてGreens Surgicals Pvt. , Ltd.を記載するその他の記録

K163383GREENS BRAND ロッキングボーンプレートおよびボルト、骨形成体術プレートシステム、GREENS BRAND Of DHS/Dynamic Condylar Plate プレートシステム

公式ソース

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