FDA 510(k)

Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT Intervertebral body fusion system

Numéro K : K233084 · 2023-11-21

Date de décision2023-11-21

Code produitODP

Comité consultatifOR

DécisionSubstantially Equivalent

Résumé du dispositif

Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT 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 2023-11-21 under 510(k) number K233084. 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 Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT Intervertebral body fusion system?

Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT Intervertebral body fusion system is a medical device that received FDA 510(k) clearance on 2023-11-21. The listed applicant is Gbs Commonwealth Co., Ltd.. The 510(k) number is K233084.

When did Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT Intervertebral body fusion system receive FDA 510(k) clearance?

Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT Intervertebral body fusion system received FDA 510(k) clearance on 2023-11-21, under 510(k) number K233084.

Who is the listed applicant for Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT 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-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT Intervertebral body fusion system?

The FDA product code for Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT Intervertebral body fusion system is ODP.

Essais cliniques associés

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Autres dossiers indiquant Gbs Commonwealth Co., Ltd. en tant que demandeur

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Dispositifs connexes (Code : ODP)

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Source officielle

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