Materialise Shoulder System, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner— 510(k) K212569
Substantially EquivalentMaterialise NV
FDA 510(k) clearance K212569 for Materialise Shoulder System, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner, Substantially Equivalent on 2022-01-12. Applicant: Materialise NV.
Clearance details
- Applicant
- Materialise NV
- Product code
- Code QHE
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Leuven, BE
Data sourced from openFDA. This site is unofficial and independent of the FDA.