K241128
- 510(k) number
- K241128
- Device name
- TDM Plate and Screw System
- Applicant
- Tdm Co., Ltd. KR
- Product code
- HRS — Plate, Fixation, Bone
- Decision date
- 2024-12-05
- Date received
- 2024-04-24
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain
Also available from FDA: K241128.pdf
Official FDA record: K241128
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.