Stabilis SA Cervical Stand-Alone System (Various PNs)— 510(k) K251735

Name: FDA 510(k) clearance K251735
Creator: U.S. Food and Drug Administration
Published: 2025-07-30

Substantially Equivalent

Acuity Surgical Devices, LLC

FDA 510(k) clearance K251735 for Stabilis SA Cervical Stand-Alone System (Various PNs), Substantially Equivalent on 2025-07-30. Applicant: Acuity Surgical Devices, LLC. Device class: 2.

Clearance details

Applicant: Acuity Surgical Devices, LLC
Product code: Code OVE
Device class: Class 2
Regulation: 21 CFR 888.3080
Advisory panel: Orthopedic
Date received: 2025-06-06
Decision date: 2025-07-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irving, TX, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code OVE

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K261882 — Pisces-SC Standalone Cervical Interbody System2026-08-21
K261451 — ZSAlign Cervical Interbody System2026-07-31
K262094 — E3D-C Interbody System2026-07-22
K261279 — DeltaNEC Interbody System2026-06-22
K252982 — CONDUIT ZERO-P VA Secured Spacer System2026-06-18

More clearances from Acuity Surgical Devices, LLC

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K251335 — Tera Lumbar Interbody Fusion System (Various PNs)2025-06-02
K243386 — Ventris Intervertebral Body Fusion Device2025-04-22
K241413 — sagAlign Lumbar Cage System (Various PNs)2024-07-17
K230639 — Align Cervical Interbody Fusion System2023-12-01
K222561 — Align2022-09-23

Adverse events under product code OVE

product code OVE

Injury: 293
Malfunction: 710
Total: 1,003

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.