K253640
- 510(k) number
- K253640
- Device name
- T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction System
- Applicant
- Stryker GmbH CH
- Product code
- HSB — Rod, Fixation, Intramedullary And Accessories
- Decision date
- 2026-02-03
- Date received
- 2025-11-19
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 1.2 MB · U.S. public domain
Also available from FDA: K253640.pdf
Official FDA record: K253640
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.