FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
EDEN Spinal Fixation MIS System
K Number: K230762
·
Decision Jun 15, 2023
Classifications
1
FEI Numbers
407
Registration Numbers
407
Same Product Code
900
Applicant Total
4
Review Days
87
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Basic Information
- Device Name
- EDEN Spinal Fixation MIS System
- K Number
- K230762
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3070
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Jmt Co., Ltd.
- Date Received
- March 20, 2023
- Decision Date
- June 15, 2023
- Product Code
- NKB
- 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 |
|---|---|---|---|
| NKB | Thoracolumbosacral Pedicle Screw System | FDA class 2 | Orthopedic |
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