510(k) K243386

Ventris Intervertebral Body Fusion Device by Acuity Surgical Devices, LLC — Product Code OVD

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: April 22, 2025
Date Received: October 31, 2024
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Intervertebral Fusion Device With Integrated Fixation, Lumbar
Device Class: Class II
Regulation Number: 888.3080
Review Panel: OR
Submission Type

Intended to stabilize lumbar spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft with or without supplemental fixation.

Other clearances by Acuity Surgical Devices, LLC

K251735 — Stabilis SA Cervical Stand-Alone System (Various PNs) (July 30, 2025)
K251335 — Tera Lumbar Interbody Fusion System (Various PNs) (June 2, 2025)
K241413 — sagAlign Lumbar Cage System (Various PNs) (July 17, 2024)
K230639 — Align Cervical Interbody Fusion System (December 1, 2023)
K222561 — Align (September 23, 2022)
K221535 — Align Lumbar Interbody Fusion System (July 22, 2022)
K201671 — A-Link Z (May 4, 2021)

Other clearances for product code OVD

K253559 — Ventana A Anterior Lumbar Interbody System (February 25, 2026)
K251829 — DeGen Medical Patient Specific Implant (PSI) System (December 8, 2025)
K251575 — IdentiTi II ALIF Standalone Interbody System; Transcend ALIF Standalone Interb (September 3, 2025)
K250072 — CONDUIT SYNFIX Evolution Secured Spacer System (July 10, 2025)
K251644 — ProAM ALIF System (June 24, 2025)
K250845 — Curiteva Porous PEEK Standalone ALIF System (June 18, 2025)
K251459 — OneLIF Interbody Fusion System (June 12, 2025)
K243934 — Stable-L Lumbar Interbody System (April 30, 2025)
K250603 — AxTiHA® Stand-Alone ALIF System (March 24, 2025)
K243802 — aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lu (March 17, 2025)