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Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase …
FDA 510(k)Class II (US FDA 510(k))
510(k) K233408
Identifiers
- 510(k) Number
- K233408 FDA 510(k)
- FDA Product Code
- QHE FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3660 FDA 510(k)
- Regulation Number
- 888.3660 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Materialise Shoulder System is a medical device designed for shoulder arthroplasty implantation, providing a minimally invasive solution for patients seeking surgical alternatives to traditional procedures. By leveraging advanced technologies and expert guidance, this system offers a streamlined process for surgeons, enabling them to achieve superior outcomes while minimizing recovery times.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K233408 | Class II | Active |
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Manufacturer
- Manufacturer
- Materialise NV
Sources (1)
- FDA 510(k) K233408 24 fields · synced Jul 30, 2026