K230507
- 510(k) number
- K230507
- Device name
- Zimed Distal Medial Tibial Plate and Screw System
- Applicant
- Zimed Medikal TR
- Product code
- HWC — Screw, Fixation, Bone
- Decision date
- 2024-01-04
- Date received
- 2023-02-24
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 3.1 MB · U.S. public domain
Also available from FDA: K230507.pdf
Official FDA record: K230507
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.