FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CODA Anterior Cervical Plate System
K Number: K230993
·
Decision Jun 20, 2023
Classifications
1
FEI Numbers
356
Registration Numbers
356
Same Product Code
665
Applicant Total
2
Review Days
75
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
- CODA Anterior Cervical Plate System
- K Number
- K230993
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3060
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Pioneer Surgical Technology, Inc D.B.A Resolve Surgical Tech
- Date Received
- April 6, 2023
- Decision Date
- June 20, 2023
- 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 Pioneer Surgical Technology, Inc D.B.A Resolve Surgical Tech
| K Number | Device Name | ||
|---|---|---|---|
| K220244 | DVR® Crosslock Wrist Spanning Plate (131849181) | Apr 28, 2022 | Substantially Equivalent |