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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 the device name listed in this FDA 510(k) record. The listed applicant is Acuity Surgical Devices, LLC. It received FDA 510(k) clearance on 2025-04-22 under 510(k) 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. The listed applicant is Acuity Surgical Devices, LLC. The 510(k) number is K243386.

When did Ventris Intervertebral Body Fusion Device receive FDA 510(k) clearance?

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

Who is the listed applicant for Ventris Intervertebral Body Fusion Device?

The FDA 510(k) record lists Acuity Surgical Devices, LLC as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Acuity Surgical Devices, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251735Stabilis SA Cervical Stand-Alone System (Various PNs)K251335Tera Lumbar Interbody Fusion System (Various PNs)K241413sagAlign Lumbar Cage System (Various PNs)K230639Align Cervical Interbody Fusion SystemK222561AlignK221535Align Lumbar Interbody Fusion System

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Related Devices (Code: OVD)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261408SABER-XA SystemElevation SpineK261809Interwedge® Standalone LateralFoundation Surgical GroupK261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar Anchor SystemKyocera Medical Technologies, Inc.K260810Anteralign LS coverplateTyber Medical, LLCK254202MectaLIF 3D Metal AnteriorMedacta International S.A.K253401SCRIPT™ Implant SystemGlobus Medical, 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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