K241983
- 510(k) number
- K241983
- Device name
- Fassier-Duval Telescoping IM System
- Applicant
- Orthopediatrics Canada Ulc Dba Pega Medical CA
- Product code
- HSB — Rod, Fixation, Intramedullary And Accessories
- Decision date
- 2025-02-21
- Date received
- 2024-07-08
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 4.4 MB · U.S. public domain
Also available from FDA: K241983.pdf
Official FDA record: K241983
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.