Materialise Shoulder Guide and Models, Materialise SurgiCase Shoulder Planner, Materialise Shoulder Planner, SurgiCase Shoulder Planner, SurgiCase Planner— 510(k) K193560
Substantially EquivalentMaterialise NV
FDA 510(k) clearance K193560 for Materialise Shoulder Guide and Models, Materialise SurgiCase Shoulder Planner, Materialise Shoulder Planner, SurgiCase Shoulder Planner, SurgiCase Planner, Substantially Equivalent on 2020-03-20. Applicant: Materialise NV. Device class: 2.
Clearance details
- Applicant
- Materialise NV
- Product code
- Code QHE
- Device class
- Class 2
- Regulation
- 21 CFR 888.3660
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Leuven, BE
Recent devices under product code QHE
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Data sourced from openFDA. This site is unofficial and independent of the FDA.