K261481
- 510(k) number
- K261481
- Device name
- Pangea Femur Reconstruction System
- Applicant
- Stryker GmbH CH
- Product code
- HSB — Rod, Fixation, Intramedullary And Accessories
- Decision date
- 2026-06-29
- Date received
- 2026-05-05
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K261481.pdf
Official FDA record: K261481
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.