K234031
- 510(k) number
- K234031
- Device name
- Medline UNITE Ancillary Foot Recon Plating System
- Applicant
- Medline Industires, LP IL · US
- Product code
- HRS — Plate, Fixation, Bone
- Decision date
- 2024-01-18
- Date received
- 2023-12-20
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K234031.pdf
Official FDA record: K234031
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.