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FDA 510(k)

Ventana™ A Anterior Lumbar Interbody System

K-Number: K253559 · 2026-02-25

ApplicantSpinal Elements, Inc.
Decision Date2026-02-25
Product CodeOVD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Ventana™ A Anterior Lumbar Interbody System is a medical device manufactured by Spinal Elements, Inc.. It received FDA 510(k) clearance on 2026-02-25 under approval number K253559. The device is classified under product code OVD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Ventana™ A Anterior Lumbar Interbody System?

Ventana™ A Anterior Lumbar Interbody System is a medical device that received FDA 510(k) clearance on 2026-02-25. It is manufactured by Spinal Elements, Inc.. The 510(k) number is K253559.

When was Ventana™ A Anterior Lumbar Interbody System approved by the FDA?

Ventana™ A Anterior Lumbar Interbody System received FDA 510(k) clearance on 2026-02-25, under approval number K253559.

What company makes Ventana™ A Anterior Lumbar Interbody System?

Ventana™ A Anterior Lumbar Interbody System is manufactured by Spinal Elements, Inc..

What is the FDA product code for Ventana™ A Anterior Lumbar Interbody System?

The FDA product code for Ventana™ A Anterior Lumbar Interbody System is OVD.

Related Clinical Trials

NCT07301385 Evaluation of Head-Mounted Spatial Computing and Three-Dimensional (3D) Visualization in Ocular Microsurgery: A Safety and Workflow Study ACTIVE_NOT_RECRUITING NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT05508360 "Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nulcectomy" (LOPAIN2) RECRUITING NCT06462729 LDGraft in Single Level Anterior Lumbar Interbody Fusion (ALIF) RECRUITING NCT05438719 MOTUS Total Joint Replacement Investigational Device Exemption Study ACTIVE_NOT_RECRUITING NCT01630707 Evaluation of the Delivery of Optimized Supersaturated Oxygen Therapy to Treat Patients With an Acute Heart Attack COMPLETED

Related PubMed Literature

PMID: 41166829 Assessment of intra-operative impact durability of additively manufactured mock lumbar intervertebral body fusion devices. Journal of biomechanics (2026)

Other Devices by Spinal Elements, Inc.

K153352Vertu® & Vertu® Ti-Bond and Crystal® & Crystal® Ti-Bond Cervical Interbody System K160465Spinal Elements' Spinous Process Plate System K152011Lucent Intervertebral Body Fusion Device K170235Lucent® K182584Lucent® XP K181837Spinal Elements Ti-Bond coated devices

View all 24 devices →

Related Devices (Code: OVD)

K162680SOVEREIGN® Spinal SystemMedtronic Sofamor Danek USA, Inc. K162351SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion DeviceSeaSpine Orthopedics Corporation K161993Leva® Anterior Interbody SystemSpine Wave, Inc. K161379ELSA SpacersGlobus Medical, Inc. K161173Avenue® T TLIF CageLdr Spine USA, Inc. K161129PILLAR SA PTCOrthofix, Inc.

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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