FDA 510(k)

Prase PEEK Anterior Cervical Interbody Spacer

Numéro K : K202872 · 2021-02-04

Date de décision2021-02-04

Code produitODP

Comité consultatifOR

DécisionSubstantially Equivalent

Résumé du dispositif

Prase PEEK Anterior Cervical Interbody Spacer is the device name listed in this FDA 510(k) record. The listed applicant is Gbs Commonwealth Co., Ltd.. It received FDA 510(k) clearance on 2021-02-04 under 510(k) number K202872. The device is classified under product code ODP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Prase PEEK Anterior Cervical Interbody Spacer?

Prase PEEK Anterior Cervical Interbody Spacer is a medical device that received FDA 510(k) clearance on 2021-02-04. The listed applicant is Gbs Commonwealth Co., Ltd.. The 510(k) number is K202872.

When did Prase PEEK Anterior Cervical Interbody Spacer receive FDA 510(k) clearance?

Prase PEEK Anterior Cervical Interbody Spacer received FDA 510(k) clearance on 2021-02-04, under 510(k) number K202872.

Who is the listed applicant for Prase PEEK Anterior Cervical Interbody Spacer?

The FDA 510(k) record lists Gbs Commonwealth Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Prase PEEK Anterior Cervical Interbody Spacer?

The FDA product code for Prase PEEK Anterior Cervical Interbody Spacer is ODP.

Essais cliniques associés

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Dispositifs connexes (Code : ODP)

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Source officielle

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