Sovereign Posterior Cervical System— 510(k) K250866

Clearance details

Applicant

Met One Technologies, LLC

Product code

Code NKG

Device class

Class 2

Regulation

21 CFR 888.3075

Advisory panel

Orthopedic

Date received

2025-03-24

Decision date

2025-05-20

Decision

Substantially Equivalent

Clearance type

Traditional

Location

El Paso, TX, US

• K253195 — TAURUS Posterior Occipital-Cervico-Thoracic Spinal Systems2026-06-02
• K254045 — CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw System2026-03-16
• K254165 — Infinity OCT System2026-01-21
• K252327 — CMORE® CT System; CMORE® CT System Navigated Instruments2025-11-12
• K253129 — Infinity OCT System2025-10-24

• K251732 — Wrist Fracture System2026-02-12
• K230851 — Kodiak Lumbar Spacer System2023-05-26
• K222806 — Kodiak C Spinal Implant System2022-12-22

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 →