K253749
- 510(k) number
- K253749
- Device name
- Affixus® Natural Nail® Proximal Humeral System
- Applicant
- Zimmer Switzerland Manufacturing GmbH CH
- Product code
- HSB — Rod, Fixation, Intramedullary And Accessories
- Decision date
- 2025-12-12
- Date received
- 2025-11-25
- 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: K253749.pdf
Official FDA record: K253749
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.