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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 a medical device manufactured by Expanding Innovations, Inc.. It received FDA 510(k) clearance on 2025-05-20 under approval 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. It is manufactured by Expanding Innovations, Inc.. The 510(k) number is K250602.

When was X-PAC® N-GAGE™ Lumbar Plate System approved by the FDA?

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

What company makes X-PAC® N-GAGE™ Lumbar Plate System?

X-PAC® N-GAGE™ Lumbar Plate System is manufactured by Expanding Innovations, Inc..

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.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT05508360 "Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nulcectomy" (LOPAIN2) RECRUITING NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION NCT07277803 Device-Based vs Manual Sensory Training in Low Back Pain NOT_YET_RECRUITING NCT06011551 HYDRAFIL-D: HYDRogel Augmentation For Intervertebral Lumbar Discs RECRUITING NCT07494812 Examining the Feasibility of Using Pressure Gradient Regulated Automated Cerebral Spinal Fluid Drainage During External Lumbar Drain Trials NOT_YET_RECRUITING

Other Devices by Expanding Innovations, Inc.

K201145X-Pac Expandable Lumbar Cage System K203802X-Pac Expandable Lumbar Cage System K222797X-Pac Expandable Lumbar Cage System K220655X-Pac Expandable Lumbar Cage System K223174X-Pac Expandable LLIF Cage System K251003X-PAC® LLIF Expandable Lateral Cage System

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Related Devices (Code: KWQ)

K160982Sphynx™Eden Spine, LLC K162638CETRA Anterior Cervical Plate SystemOrthofix, Inc. K162194MEDICREA INTERNATIONAL Anterior Cervical Locking Plate SystemMedicrea International SA K162211AccuFit Lateral Plate SystemPrecision Spine, Inc. K162250FortiBridge Anterior Cervical Plate SystemNanovis Spine, LLC K162664Pyrenees Cervical Plate SystemK2m, 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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