K253566
- 510(k) number
- K253566
- Device name
- Affixus Retrograde Femoral Nailing System
- Applicant
- Zimmer, Inc. IN · US
- Product code
- HSB — Rod, Fixation, Intramedullary And Accessories
- Decision date
- 2026-03-12
- Date received
- 2025-11-17
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K253566.pdf
Official FDA record: K253566
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.