FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
Femur Reconstruction Interlocking Nail System, Femur Retrograde Interlocking Nail System, Humerus Interlocking Nail System, Tibia Interlocking Nail System, Compression Hip Nail System
K Number: K230071
·
Decision Aug 22, 2024
Classifications
1
FEI Numbers
302
Registration Numbers
302
Same Product Code
528
Applicant Total
11
Review Days
590
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Basic Information
- Device Name
- Femur Reconstruction Interlocking Nail System, Femur Retrograde Interlocking Nail System, Humerus Interlocking Nail System, Tibia Interlocking Nail System, Compression Hip Nail System
- K Number
- K230071
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3020
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Tdm Co., Ltd.
- Date Received
- January 10, 2023
- Decision Date
- August 22, 2024
- Product Code
- HSB
- 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 |
|---|---|---|---|
| HSB | Rod, Fixation, Intramedullary And Accessories | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HSB), ordered by most recent decision date.
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| K190391 | TDM Plate and Screw Systems | Nov 15, 2019 | Substantially Equivalent |
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| K171808 | TDM Plate and Screw System | Mar 15, 2018 | Substantially Equivalent |