Materialise Shoulder System, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner— 510(k) K231112
Substantially EquivalentMaterialise NV
FDA 510(k) clearance K231112 for Materialise Shoulder System, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner, Substantially Equivalent on 2023-09-12. 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.