Edge Upper Cervical System— 510(k) K221307

Clearance details

Applicant

Spinal Simplicity, LLC

Product code

Code NKG

Device class

Class 2

Regulation

21 CFR 888.3075

Advisory panel

Orthopedic

Date received

2022-05-05

Decision date

2023-07-10

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Overland Park, KS, US

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• K240592 — Wolff's Law Anterior Cervical Plate System2024-05-24
• K232259 — Patriot-SI Posterior Implant System2024-04-19
• K234051 — Minuteman G5 MIS Fusion Plate +3 more2024-01-18

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 →