X-PAC® N-GAGE Lumbar Plate System— 510(k) K250602

Name: FDA 510(k) clearance K250602
Creator: U.S. Food and Drug Administration
Published: 2025-05-20

Substantially Equivalent

Expanding Innovations, Inc.

FDA 510(k) clearance K250602 for X-PAC® N-GAGE Lumbar Plate System, Substantially Equivalent on 2025-05-20. Applicant: Expanding Innovations, Inc.. Device class: 2.

Clearance details

Applicant: Expanding Innovations, Inc.
Product code: Code KWQ
Device class: Class 2
Regulation: 21 CFR 888.3060
Advisory panel: Orthopedic
Date received: 2025-02-28
Decision date: 2025-05-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mountain View, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KWQ

view all

K261309 — Palisades Buttress Plate System2026-07-16
K252776 — ARIES Anterior Cervical Plate Systems2026-05-14
K261112 — CastleLoc-P Anterior Cervical Plate System2026-05-06
K260570 — corra cervical plating system2026-04-22
K260697 — VyPlate Anterior Cervical Plate System2026-03-27

More clearances from Expanding Innovations, Inc.

view all

K251003 — X-PAC® LLIF Expandable Lateral Cage System2025-06-25
K251617 — X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage System2025-06-16
K223174 — X-Pac Expandable LLIF Cage System2023-02-14
K222797 — X-Pac Expandable Lumbar Cage System2022-10-14
K220655 — X-Pac Expandable Lumbar Cage System2022-03-24

Adverse events under product code KWQ

product code KWQ

Death: 8
Injury: 1,212
Malfunction: 1,233
Total: 2,453

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.