510(k) K230071
K230071 is an FDA 510(k) premarket notification submitted by Tdm Co., Ltd. for the device "Femur Reconstruction Interlocking Nail System, Femur Retrograde Interlocking Nail System, Humerus Interlocking Nail System, Tibia Interlocking Nail System, Compression Hip Nail System". The FDA issued a decision of Substantially Equivalent on August 22, 2024. The device falls under product code HSB (Rod, Fixation, Intramedullary And Accessories), a Class II device regulated under 21 CFR 888.3020. Tdm Co., Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 22, 2024
- Date Received
- January 10, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Rod, Fixation, Intramedullary And Accessories
- Device Class
- Class II
- Regulation Number
- 888.3020
- Review Panel
- OR
- Submission Type