Rampart One Lumbar Interbody Fusion Device— 510(k) K180002

Name: FDA 510(k) clearance K180002
Creator: U.S. Food and Drug Administration
Published: 2018-04-25

Substantially Equivalent

Spineology, Inc.

FDA 510(k) clearance K180002 for Rampart One Lumbar Interbody Fusion Device, Substantially Equivalent on 2018-04-25. Applicant: Spineology, Inc.. Device class: 2.

Clearance details

Applicant: Spineology, Inc.
Product code: Code OVD
Device class: Class 2
Regulation: 21 CFR 888.3080
Advisory panel: Orthopedic
Date received: 2018-01-02
Decision date: 2018-04-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Saint Paul, MN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code OVD

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K260810 — Anteralign LS coverplate2026-06-10

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K230927 — OptiMesh Multiplanar Expandable Interbody Fusion System2023-11-01
K231781 — OptiMesh Multiplanar Expandable Interbody Fusion System2023-10-18
K213876 — Spineology Navigation Instruments2022-08-05

Adverse events under product code OVD

product code OVD

Death: 5
Injury: 495
Total: 500

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.