Align Cervical Interbody Fusion System— 510(k) K230639

Name: FDA 510(k) clearance K230639
Creator: U.S. Food and Drug Administration
Published: 2023-12-01

Substantially Equivalent

Acuity Surgical Devices, LLC

FDA 510(k) clearance K230639 for Align Cervical Interbody Fusion System, Substantially Equivalent on 2023-12-01. Applicant: Acuity Surgical Devices, LLC. Device class: 2.

Clearance details

Applicant: Acuity Surgical Devices, LLC
Product code: Code ODP
Device class: Class 2
Regulation: 21 CFR 888.3080
Advisory panel: Orthopedic
Date received: 2023-03-08
Decision date: 2023-12-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irving, TX, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code ODP

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K262595 — VariLift-C Cervical Interbody Fusion System2026-08-26
K262489 — BluEX Cervical Expandable Cage System2026-08-18
K253041 — 3d Cage Cervical2026-07-23
K262061 — Tritanium® C Anterior Cervical Cage +16 more2026-07-17
K254130 — C.A. Medical Interbody Fusion System2026-07-08

More clearances from Acuity Surgical Devices, LLC

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K251735 — Stabilis SA Cervical Stand-Alone System (Various PNs)2025-07-30
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
K222561 — Align2022-09-23

Adverse events under product code ODP

product code ODP

Injury: 310
Total: 310

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.