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FDA 510(k)

Pegasus-X Expandable PLIF System

K-Number: K221687 · 2022-07-27

ApplicantGS Medical Co., Ltd.
Decision Date2022-07-27
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Pegasus-X Expandable PLIF System is a medical device manufactured by GS Medical Co., Ltd.. It received FDA 510(k) clearance on 2022-07-27 under approval number K221687. 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 Pegasus-X Expandable PLIF System?

Pegasus-X Expandable PLIF System is a medical device that received FDA 510(k) clearance on 2022-07-27. It is manufactured by GS Medical Co., Ltd.. The 510(k) number is K221687.

When was Pegasus-X Expandable PLIF System approved by the FDA?

Pegasus-X Expandable PLIF System received FDA 510(k) clearance on 2022-07-27, under approval number K221687.

What company makes Pegasus-X Expandable PLIF System?

Pegasus-X Expandable PLIF System is manufactured by GS Medical Co., Ltd..

What is the FDA product code for Pegasus-X Expandable PLIF System?

The FDA product code for Pegasus-X Expandable PLIF System is MAX.

Related Clinical Trials

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Related Devices (Code: MAX)

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Official Source

View on FDA Database →

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

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