ORIO-Ti Intervertebral Body Fusion Cage System— 510(k) K211935

Substantially Equivalent

Spinecraft, LLC

FDA 510(k) clearance K211935 for ORIO-Ti Intervertebral Body Fusion Cage System, Substantially Equivalent on 2021-09-30. Applicant: Spinecraft, LLC.

Clearance details

Applicant: Spinecraft, LLC
Product code: Code ODP
Advisory panel: Orthopedic
Date received: 2021-06-22
Decision date: 2021-09-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Westmont, IL, US

Download summary PDF View on FDA.gov ↗

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.