FDA 510(k)

Peridot-EX Expandable Intervertebral Body Fusion System

K-Number: K232292 · 2023-11-07

Decision Date2023-11-07

Product CodeMAX

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

Other records listing Gbs Commonwealth Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.