DeviceClearance

Ventana® P/T Lumbar Interbody System— 510(k) K260506

Substantially Equivalent

Spinal Elements, Inc.

FDA 510(k) clearance K260506 for Ventana® P/T Lumbar Interbody System, Substantially Equivalent on 2026-05-15. Applicant: Spinal Elements, Inc.. Device class: 2.

Summary

Spinal Elements' Ventana P/T Lumbar Interbody System is filed under MAX, lumbar intervertebral fusion devices with bone graft.

Class II, 21 CFR 888.3080. Orthopedic is both the classification panel and the review panel. The submission was a Traditional 510(k).

Spinal Elements filed from Carlsbad, California. Review took 87 calendar days (February 17 to May 15, 2026).

Clearance details

Applicant
Spinal Elements, Inc.
Product code
Product code MAX
Device class
Class 2
Regulation
21 CFR 888.3080
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Carlsbad, CA, US
Download summary PDFView 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, through . 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.