FDA 510(k)
FDA class 2
Substantially Equivalent
🇧🇪 Belgium
Materialise Shoulder System, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner
K Number: K260802
·
Decision Jun 9, 2026
Classifications
1
FEI Numbers
35
Registration Numbers
35
Same Product Code
25
Applicant Total
61
Review Days
90
Basic Information
- Device Name
- Materialise Shoulder System, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner
- K Number
- K260802
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3660
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Materialise NV
- Date Received
- March 11, 2026
- Decision Date
- June 9, 2026
- Product Code
- QHE
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| QHE | Shoulder Arthroplasty Implantation System | FDA class 2 | Orthopedic |
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