X-Pac Expandable LLIF Cage System— 510(k) K223174

Name: FDA 510(k) clearance K223174
Creator: U.S. Food and Drug Administration
Published: 2023-02-14

Substantially Equivalent

Expanding Innovations, Inc.

FDA 510(k) clearance K223174 for X-Pac Expandable LLIF Cage System, Substantially Equivalent on 2023-02-14. Applicant: Expanding Innovations, Inc.. Device class: 2.

Clearance details

Applicant: Expanding Innovations, Inc.
Product code: Code MAX
Device class: Class 2
Regulation: 21 CFR 888.3080
Advisory panel: Orthopedic
Date received: 2022-10-11
Decision date: 2023-02-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mountain View, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MAX

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K261049 — SCALA® TL2026-08-20
K261430 — TruLift Expandable System2026-07-28
K253011 — Catalyft PL Expandable Interbody System2026-07-17
K261020 — Symmetrix L Spinal System2026-07-14
K253420 — Admiral ACP System +18 more2026-07-01

More clearances from Expanding Innovations, Inc.

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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
K250602 — X-PAC® N-GAGE Lumbar Plate System2025-05-20
K222797 — X-Pac Expandable Lumbar Cage System2022-10-14
K220655 — X-Pac Expandable Lumbar Cage System2022-03-24

Adverse events under product code MAX

product code MAX

Death: 13
Injury: 1,305
Malfunction: 2,885
Total: 4,203

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.