FDA 510(k)

Peridot-EX Expandable Intervertebral Body Fusion System

Numéro K : K232292 · 2023-11-07

Date de décision2023-11-07

Code produitMAX

Comité consultatifOR

DécisionSubstantially Equivalent

Résumé du dispositif

Peridot-EX Expandable Intervertebral Body Fusion System 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 2023-11-07 under 510(k) number K232292. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Peridot-EX Expandable Intervertebral Body Fusion System?

Peridot-EX Expandable Intervertebral Body Fusion System is a medical device that received FDA 510(k) clearance on 2023-11-07. The listed applicant is Gbs Commonwealth Co., Ltd.. The 510(k) number is K232292.

When did Peridot-EX Expandable Intervertebral Body Fusion System receive FDA 510(k) clearance?

Peridot-EX Expandable Intervertebral Body Fusion System received FDA 510(k) clearance on 2023-11-07, under 510(k) number K232292.

Who is the listed applicant for Peridot-EX Expandable Intervertebral Body Fusion System?

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 Peridot-EX Expandable Intervertebral Body Fusion System?

The FDA product code for Peridot-EX Expandable Intervertebral Body Fusion System is MAX.

Essais cliniques associés

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Source officielle

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