T-FIX® 3DSI Joint Fusion System— 510(k) K214123

Substantially Equivalent

Cutting Edge Spine, LLC

FDA 510(k) clearance K214123 for T-FIX® 3DSI Joint Fusion System, Substantially Equivalent on 2022-06-24. Applicant: Cutting Edge Spine, LLC.

Clearance details

Applicant: Cutting Edge Spine, LLC
Product code: Code OUR
Advisory panel: Orthopedic
Date received: 2021-12-30
Decision date: 2022-06-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mineral Springs, NC, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code OUR

product code OUR

Death: 3
Injury: 347
Total: 350

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.