FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
Dyflex-II
K Number: K212700
·
Decision Nov 15, 2022
Classifications
1
FEI Numbers
407
Registration Numbers
407
Same Product Code
900
Applicant Total
3
Review Days
447
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Basic Information
- Device Name
- Dyflex-II
- K Number
- K212700
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3070
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Taeyeon Medical Co., Ltd.
- Date Received
- August 25, 2021
- Decision Date
- November 15, 2022
- 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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