Cyclops Anterior Cervical Plate System— 510(k) K213901

Clearance details

Applicant

Degen Medical

Product code

Code KWQ

Device class

Class 2

Regulation

21 CFR 888.3060

Advisory panel

Orthopedic

Date received

2021-12-14

Decision date

2022-01-07

Decision

Substantially Equivalent

Clearance type

Special

Location

Florence, SC, US

• K261309 — Palisades Buttress Plate System2026-07-16
• K252776 — ARIES Anterior Cervical Plate Systems2026-05-14
• K261112 — CastleLoc-P Anterior Cervical Plate System2026-05-06
• K260570 — corra cervical plating system2026-04-22
• K260697 — VyPlate Anterior Cervical Plate System2026-03-27

• K251829 — DeGen Medical Patient Specific Implant (PSI) System2025-12-08
• K252737 — DeGen Medical Latitude-C AM Cervical Interbody Fusion System2025-10-10
• K250667 — DeGen Medical Patient Specific Implant (PSI) System2025-04-04
• K241077 — DeGen Medical Patient Specific Implant (PSI) System2024-10-29
• K231199 — Solar Lumbar Interbody Fusion System2023-06-16

Death

8

Injury

1,212

Malfunction

1,233

Total

2,453

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 →