K241651
- 510(k) number
- K241651
- Device name
- Affixus Tibial and Antegrade Femoral Nailing System
- Applicant
- Zimmer, Inc. IN · US
- Product code
- HSB — Rod, Fixation, Intramedullary And Accessories
- Decision date
- 2024-09-26
- Date received
- 2024-06-07
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 2.3 MB · U.S. public domain
Also available from FDA: K241651.pdf
Official FDA record: K241651
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.