Rampart-T Interbody Fusion System— 510(k) K151020

Substantially Equivalent

Spineology, Inc.

FDA 510(k) clearance K151020 for Rampart-T Interbody Fusion System, Substantially Equivalent on 2015-07-22. Applicant: Spineology, Inc..

Clearance details

Applicant: Spineology, Inc.
Product code: Code MAX
Advisory panel: Orthopedic
Date received: 2015-04-16
Decision date: 2015-07-22
Decision: Substantially Equivalent
Clearance type: Special
Location: St. Paul, MN, US

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Adverse events under product code MAX

product code MAX

Death: 13
Injury: 1,305
Malfunction: 2,885
Total: 4,203

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.