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FDA 510(k)

Ventris Intervertebral Body Fusion Device

K-Number: K243386 · 2025-04-22

ApplicantAcuity Surgical Devices, LLC
Decision Date2025-04-22
Product CodeOVD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Ventris Intervertebral Body Fusion Device is a medical device manufactured by Acuity Surgical Devices, LLC. It received FDA 510(k) clearance on 2025-04-22 under approval number K243386. 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 Ventris Intervertebral Body Fusion Device?

Ventris Intervertebral Body Fusion Device is a medical device that received FDA 510(k) clearance on 2025-04-22. It is manufactured by Acuity Surgical Devices, LLC. The 510(k) number is K243386.

When was Ventris Intervertebral Body Fusion Device approved by the FDA?

Ventris Intervertebral Body Fusion Device received FDA 510(k) clearance on 2025-04-22, under approval number K243386.

What company makes Ventris Intervertebral Body Fusion Device?

Ventris Intervertebral Body Fusion Device is manufactured by Acuity Surgical Devices, LLC.

What is the FDA product code for Ventris Intervertebral Body Fusion Device?

The FDA product code for Ventris Intervertebral Body Fusion Device is OVD.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT06462729 LDGraft in Single Level Anterior Lumbar Interbody Fusion (ALIF) RECRUITING NCT05438719 MOTUS Total Joint Replacement Investigational Device Exemption Study ACTIVE_NOT_RECRUITING NCT02759744 Fusion Guided Focal Laser Ablation of Prostate Cancer ENROLLING_BY_INVITATION NCT07516145 Robotic Transjugular Transcatheter Tricuspid Valve Replacement RECRUITING NCT04214535 Anterior Cervical Disectomy And Fusion Using The Tritanium® C Anterior Cervical Cage For One Or Two-Levels ACTIVE_NOT_RECRUITING

Related PubMed Literature

PMID: 41839575 A Perspective for Integrating Real-World Evidence Into the Investigational Device Exemption Study Design for Lumbar Total Joint Replacement. International journal of spine surgery (2026) PMID: 41166829 Assessment of intra-operative impact durability of additively manufactured mock lumbar intervertebral body fusion devices. Journal of biomechanics (2026)

Other Devices by Acuity Surgical Devices, LLC

K201671A-Link Z K222561Align K221535Align Lumbar Interbody Fusion System K230639Align Cervical Interbody Fusion System K241413sagAlign Lumbar Cage System (Various PNs) K251735Stabilis SA Cervical Stand-Alone System (Various PNs)

View all 8 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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