Femur Reconstruction Interlocking Nail System, Femur Retrograde Interlocking Nail System, Humerus Interlocking Nail System, Tibia Interlocking Nail System, Compression Hip Nail System
FDA 510(k) clearance K230071 · decided 2024-08-22
Clearance details
- K-number
- K230071
- Device name
- Femur Reconstruction Interlocking Nail System, Femur Retrograde Interlocking Nail System, Humerus Interlocking Nail System, Tibia Interlocking Nail System, Compression Hip Nail System
- Applicant
- Tdm Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2023-01-10
- Decision date
- 2024-08-22
- Days to decision
- 590 days
- Clearance type
- Traditional
- Product code
- HSB
- Device class
- 2
- Regulation number
- 888.3020
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Buk-Gu, KR
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.