K230071
- 510(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. KR
- Product code
- HSB — Rod, Fixation, Intramedullary And Accessories
- Decision date
- 2024-08-22
- Date received
- 2023-01-10
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K230071.pdf
Official FDA record: K230071
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.