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Materialise Glenoid Positioning System
FDA 510(k)Class II (US FDA 510(k))
510(k) K172054
Identifiers
- 510(k) Number
- K172054 FDA 510(k)
- FDA Product Code
- KWS 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)
Materialise Glenoid Positioning System (MGP-01) - A novel, semi-constrained shoulder replacement solution that utilizes a proprietary gliding mechanism to provide accurate and reliable positioning of the prosthetic joint. Our innovative design ensures optimal alignment and stability of the prosthesis, resulting in improved patient outcomes.
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 | K172054 | Class II | Active |
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Manufacturer
- Manufacturer
- Materialise NV
Sources (1)
- FDA 510(k) K172054 24 fields · synced Jul 3, 2026