Edge Upper Cervical System— 510(k) K221307

Substantially Equivalent

Spinal Simplicity, LLC

FDA 510(k) clearance K221307 for Edge Upper Cervical System, Substantially Equivalent on 2023-07-10. Applicant: Spinal Simplicity, LLC.

Clearance details

Applicant: Spinal Simplicity, LLC
Product code: Code NKG
Advisory panel: Orthopedic
Date received: 2022-05-05
Decision date: 2023-07-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Overland Park, KS, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code NKG

product code NKG

Death: 15
Injury: 1,090
Malfunction: 529
Total: 1,634

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.