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510(k) K250602

X-PAC® N-GAGE™ Lumbar Plate System by Expanding Innovations, Inc. — Product Code KWQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 20, 2025
Date Received
February 28, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Appliance, Fixation, Spinal Intervertebral Body
Device Class
Class II
Regulation Number
888.3060
Review Panel
OR
Submission Type

Other clearances by Expanding Innovations, Inc.

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  • K223174 — X-Pac Expandable LLIF Cage System (February 14, 2023)
  • K222797 — X-Pac Expandable Lumbar Cage System (October 14, 2022)
  • K220655 — X-Pac Expandable Lumbar Cage System (March 24, 2022)
  • K203802 — X-Pac Expandable Lumbar Cage System (June 7, 2021)
  • K201145 — X-Pac Expandable Lumbar Cage System (September 10, 2020)

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  • K250486 — Skyway Anterior Cervical Plate System (April 10, 2025)
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