SWINGO-3D Lumbar Cage System— 510(k) K254017

Name: FDA 510(k) clearance K254017
Creator: U.S. Food and Drug Administration
Published: 2026-02-26

Substantially Equivalent

Implanet

FDA 510(k) clearance K254017 for SWINGO-3D Lumbar Cage System, Substantially Equivalent on 2026-02-26. Applicant: Implanet. Device class: 2.

Summary

Implanet's SWINGO-3D Lumbar Cage System is filed under product code MAX (Intervertebral Fusion Device With Bone Graft, Lumbar). The record doesn't describe the system beyond its name and that code name.

Class II, 21 CFR 888.3080. Orthopedic is both the classification panel and the review panel. It came in as a Traditional 510(k).

The record lists the applicant location as Allee Francois Magendie, France. FDA found it substantially equivalent 73 calendar days after receipt (December 15, 2025 to February 26, 2026).

Clearance details

Applicant: Implanet
Product code: Product code MAX
Device class: Class 2
Regulation: 21 CFR 888.3080
Advisory panel: Orthopedic
Date received: 2025-12-15
Decision date: 2026-02-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Allee Francois Magendie, FR

Download summary PDF View on FDA.gov ↗

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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.