FDA 510(k)

ディスク切除术ナビゲーション対応機器およびユニバーサルナビゲーションアダプターセット

K番号: K212756 · 2022-05-05

決定日2022-05-05

製品コードOLO

諮問委員会Please provide the source text to translate.

決定大幅同等

医療機器の概要

Discectomy Navigation Ready Instruments and Universal Navigation Adaptor Set is the device name listed in this FDA 510(k) record. The listed applicant is Medos International SARL. It received FDA 510(k) clearance on 2022-05-05 under 510(k) number K212756. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Discectomy Navigation Ready Instruments and Universal Navigation Adaptor Set?

Discectomy Navigation Ready Instruments and Universal Navigation Adaptor Set is a medical device that received FDA 510(k) clearance on 2022-05-05. The listed applicant is Medos International SARL. The 510(k) number is K212756.

When did Discectomy Navigation Ready Instruments and Universal Navigation Adaptor Set receive FDA 510(k) clearance?

Discectomy Navigation Ready Instruments and Universal Navigation Adaptor Set received FDA 510(k) clearance on 2022-05-05, under 510(k) number K212756.

Who is the listed applicant for Discectomy Navigation Ready Instruments and Universal Navigation Adaptor Set?

The FDA 510(k) record lists Medos International SARL as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Discectomy Navigation Ready Instruments and Universal Navigation Adaptor Set?

The FDA product code for Discectomy Navigation Ready Instruments and Universal Navigation Adaptor Set is OLO.

申請者としてMedos International SARLを記載するその他の記録

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