FDA 510(k)

出生 PT-LIF 盒 HA

K 號：K202380 · 2021-02-19

決定日期2021-02-19

產品代碼MAX

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決定相當於

器材摘要

Born PT-LIF Cage HA is the device name listed in this FDA 510(k) record. The listed applicant is Spineworxx AG. It received FDA 510(k) clearance on 2021-02-19 under 510(k) number K202380. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Born PT-LIF Cage HA?

Born PT-LIF Cage HA is a medical device that received FDA 510(k) clearance on 2021-02-19. The listed applicant is Spineworxx AG. The 510(k) number is K202380.

When did Born PT-LIF Cage HA receive FDA 510(k) clearance?

Born PT-LIF Cage HA received FDA 510(k) clearance on 2021-02-19, under 510(k) number K202380.

Who is the listed applicant for Born PT-LIF Cage HA?

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

What is the FDA product code for Born PT-LIF Cage HA?

The FDA product code for Born PT-LIF Cage HA is MAX.

相關器械（代碼：MAX）

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