FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
TDM Anterior Cervical Plate System
K Number: K240423
·
Decision Apr 8, 2024
Classifications
1
FEI Numbers
356
Registration Numbers
356
Same Product Code
665
Applicant Total
11
Review Days
55
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
- TDM Anterior Cervical Plate System
- K Number
- K240423
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3060
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Tdm Co., Ltd.
- Date Received
- February 13, 2024
- Decision Date
- April 8, 2024
- 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 Tdm Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K241128 | TDM Plate and Screw System | Dec 5, 2024 | Substantially Equivalent |
| K230071 | Femur Reconstruction Interlocking Nail System, Femur Retrograde Interlocking Nail System, Humerus Interlocking Nail System, Tibia Interlocking Nail System, Compression Hip Nail System | Aug 22, 2024 | Substantially Equivalent |
| K232115 | TDM Large Bone Plate and Screw System | Apr 5, 2024 | Substantially Equivalent |
| K231860 | TDM Screw System | Jan 18, 2024 | Substantially Equivalent |
| K221844 | TDM Lumbar Interbody Fusion Cage System | Aug 17, 2022 | Substantially Equivalent |
| K220285 | PINE Pedicle Screw System | May 19, 2022 | Substantially Equivalent |
| K191057 | Park's Pectus System | Mar 19, 2020 | Substantially Equivalent |
| K190391 | TDM Plate and Screw Systems | Nov 15, 2019 | Substantially Equivalent |
| K190830 | TDM Screw Systems | Sep 13, 2019 | Substantially Equivalent |
| K171808 | TDM Plate and Screw System | Mar 15, 2018 | Substantially Equivalent |