FDA 510(k)

4CIS SARA脊椎システム、4CIS VERTU脊椎システム

K番号: K202498 · 2021-02-18

申請者Solco Biomedical Company India Private Limited

決定日2021-02-18

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

4CIS SARA Spine System, 4CIS VERTU Spine System is the device name listed in this FDA 510(k) record. The listed applicant is Solco Biomedical Company India Private Limited. It received FDA 510(k) clearance on 2021-02-18 under 510(k) number K202498. 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 4CIS SARA Spine System, 4CIS VERTU Spine System?

4CIS SARA Spine System, 4CIS VERTU Spine System is a medical device that received FDA 510(k) clearance on 2021-02-18. The listed applicant is Solco Biomedical Company India Private Limited. The 510(k) number is K202498.

When did 4CIS SARA Spine System, 4CIS VERTU Spine System receive FDA 510(k) clearance?

4CIS SARA Spine System, 4CIS VERTU Spine System received FDA 510(k) clearance on 2021-02-18, under 510(k) number K202498.

Who is the listed applicant for 4CIS SARA Spine System, 4CIS VERTU Spine System?

The FDA 510(k) record lists Solco Biomedical Company India Private Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 4CIS SARA Spine System, 4CIS VERTU Spine System?

The FDA product code for 4CIS SARA Spine System, 4CIS VERTU Spine System is NKB.

申請者としてSolco Biomedical Company India Private Limitedを記載するその他の記録

K2136534CIS BLACK MARLIN PLIF CAGE SYSTEM, 4CIS DOLPHIN TLIF CAGE SYSTEM

公式ソース

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