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FDA 510(k)

X-PAC® N-GAGE™ Lumbar Plate System

K-Number: K250602 · 2025-05-20

ApplicantExpanding Innovations, Inc.
Decision Date2025-05-20
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

X-PAC® N-GAGE™ Lumbar Plate System is the device name listed in this FDA 510(k) record. The listed applicant is Expanding Innovations, Inc.. It received FDA 510(k) clearance on 2025-05-20 under 510(k) number K250602. The device is classified under product code KWQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the X-PAC® N-GAGE™ Lumbar Plate System?

X-PAC® N-GAGE™ Lumbar Plate System is a medical device that received FDA 510(k) clearance on 2025-05-20. The listed applicant is Expanding Innovations, Inc.. The 510(k) number is K250602.

When did X-PAC® N-GAGE™ Lumbar Plate System receive FDA 510(k) clearance?

X-PAC® N-GAGE™ Lumbar Plate System received FDA 510(k) clearance on 2025-05-20, under 510(k) number K250602.

Who is the listed applicant for X-PAC® N-GAGE™ Lumbar Plate System?

The FDA 510(k) record lists Expanding Innovations, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for X-PAC® N-GAGE™ Lumbar Plate System?

The FDA product code for X-PAC® N-GAGE™ Lumbar Plate System is KWQ.

Other records listing Expanding Innovations, Inc. 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.

K251003X-PAC® LLIF Expandable Lateral Cage SystemK251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemK223174X-Pac Expandable LLIF Cage SystemK222797X-Pac Expandable Lumbar Cage SystemK220655X-Pac Expandable Lumbar Cage SystemK203802X-Pac Expandable Lumbar Cage System

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Related Devices (Code: KWQ)

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.

K261309Palisades™ Buttress Plate SystemBethesda Medical Devices, LLCK252776ARIES Anterior Cervical Plate SystemsZheJiang Decans Medical Devices Co., Ltd.K261112CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd.K260570corra™ cervical plating systemCarlsmed, Inc.K260697VyPlate™ Anterior Cervical Plate SystemVy Spine, LLCK260015ANTERIS Thoracolumbar Plate SystemSpineCraft

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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