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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 the device name listed in this FDA 510(k) record. The listed applicant is GS Medical Co., Ltd.. It received FDA 510(k) clearance on 2022-07-27 under 510(k) 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. The listed applicant is GS Medical Co., Ltd.. The 510(k) number is K221687.

When did Pegasus-X Expandable PLIF System receive FDA 510(k) clearance?

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

Who is the listed applicant for Pegasus-X Expandable PLIF System?

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

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

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

Other records listing GS Medical Co., Ltd. as applicant

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Related Devices (Code: MAX)

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.

K261430TruLift Expandable SystemLife Spine, Inc.K253011Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer; Meridian Interbody System; Meridian Anterior Plate System; Reef L Interbody System; Reef TO/TA System; Regatta Lateral System; Regatta Lateral Plate System; Shoreline ACS Interbody System; Shoreline Threaded TruProfile Plate; Shoreline RT Interbody System; Vu Mesh; WaveForm A Interbody System; WaveForm C Interbody System; WaveForm L Interbody System; WaveForm TA Interbody System; WaveForm TO Interbody SySeaSpine Orthopedics CorporationK253151Fule Interbody Fusion Cage SystemBeijing Fule Science & Technology Development Co., Ltd.K261159Exceed® Biplanar Expandable Interbody SystemSpine Wave, Inc.

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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