Rampart One Lumbar Interbody Fusion Device— 510(k) K163670

Substantially Equivalent

Spineology, Inc.

FDA 510(k) clearance K163670 for Rampart One Lumbar Interbody Fusion Device, Substantially Equivalent on 2017-05-08. Applicant: Spineology, Inc..

Clearance details

Applicant: Spineology, Inc.
Product code: Code OVD
Advisory panel: Orthopedic
Date received: 2016-12-27
Decision date: 2017-05-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Saint Paul, MN, US

Download summary PDF View on FDA.gov ↗

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.