FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Cyclops Anterior Cervical Plate System
K Number: K213901
·
Decision Jan 7, 2022
Classifications
1
FEI Numbers
356
Registration Numbers
356
Same Product Code
665
Applicant Total
16
Review Days
24
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- Cyclops Anterior Cervical Plate System
- K Number
- K213901
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3060
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Degen Medical
- Date Received
- December 14, 2021
- Decision Date
- January 7, 2022
- Product Code
- KWQ
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KWQ), ordered by most recent decision date.
ARIES Anterior Cervical Plate Systems
FDA 510(k)
FDA Class 2
·Orthopedic
CastleLoc-P Anterior Cervical Plate System
FDA 510(k)
FDA Class 2
·Orthopedic
corra cervical plating system
FDA 510(k)
FDA Class 2
·Orthopedic
VyPlate Anterior Cervical Plate System
FDA 510(k)
FDA Class 2
·Orthopedic
ANTERIS Thoracolumbar Plate System
FDA 510(k)
FDA Class 2
·Orthopedic
PathLoc Lumbar Plate System
FDA 510(k)
FDA Class 2
·Orthopedic
Other Clearances by Degen Medical
| K Number | Device Name | ||
|---|---|---|---|
| K251829 | DeGen Medical Patient Specific Implant (PSI) System | Dec 8, 2025 | Substantially Equivalent |
| K252737 | DeGen Medical Latitude-C AM Cervical Interbody Fusion System | Oct 10, 2025 | Substantially Equivalent |
| K250667 | DeGen Medical Patient Specific Implant (PSI) System | Apr 4, 2025 | Substantially Equivalent |
| K241077 | DeGen Medical Patient Specific Implant (PSI) System | Oct 29, 2024 | Substantially Equivalent |
| K231199 | Solar Lumbar Interbody Fusion System | Jun 16, 2023 | Substantially Equivalent |
| K223418 | DeGen Impulse AM System | Mar 17, 2023 | Substantially Equivalent |
| K213918 | DeGen Navigated Instrumentation | Feb 9, 2022 | Substantially Equivalent |
| K210090 | Impulse AM Interbody Fusion System | Aug 30, 2021 | Substantially Equivalent |
| K203816 | DeGen Navigated Instrumentation | Apr 2, 2021 | Substantially Equivalent |
| K201287 | Impulse Interbody Fusion System | Dec 22, 2020 | Substantially Equivalent |