K251554
- 510(k) number
- K251554
- Device name
- Materialise TKA Guide System
- Applicant
- Materialise NV BE
- Product code
- JWH — Prosthesis, Knee, Patellofemorotibial, Semi-Constrai
- Decision date
- 2025-07-14
- Date received
- 2025-05-21
- 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: K251554.pdf
Official FDA record: K251554
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.