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FDA 510(k)

Ventana® P/T Lumbar Interbody System

K-Number: K260506 · 2026-05-15

ApplicantSpinal Elements, Inc.
Decision Date2026-05-15
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Ventana® P/T Lumbar Interbody System is a medical device manufactured by Spinal Elements, Inc.. It received FDA 510(k) clearance on 2026-05-15 under approval number K260506. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Ventana® P/T Lumbar Interbody System?

Ventana® P/T Lumbar Interbody System is a medical device that received FDA 510(k) clearance on 2026-05-15. It is manufactured by Spinal Elements, Inc.. The 510(k) number is K260506.

When was Ventana® P/T Lumbar Interbody System approved by the FDA?

Ventana® P/T Lumbar Interbody System received FDA 510(k) clearance on 2026-05-15, under approval number K260506.

What company makes Ventana® P/T Lumbar Interbody System?

Ventana® P/T Lumbar Interbody System is manufactured by Spinal Elements, Inc..

What is the FDA product code for Ventana® P/T Lumbar Interbody System?

The FDA product code for Ventana® P/T Lumbar Interbody System is MAX.

Related Devices (Code: MAX)

K260837VersaLift Expandable SystemLife Spine, Inc. K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and transforaminal lumbar interbody system; aprevo® cervical interbody system; corra™ cervical plating systemCarlsmed, Inc. K261067BEE PLIF CageNGMedical GmbH

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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