Materialise Shoulder System, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner— 510(k) K260802
Substantially EquivalentMaterialise NV
FDA 510(k) clearance K260802 for Materialise Shoulder System, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner, Substantially Equivalent on 2026-06-09. 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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- K243637 — Materialise Personalized Guides and Models for Craniomaxillofacial Surgery
Data sourced from openFDA. This site is unofficial and independent of the FDA.