Identifiers
- 510(k) Number
- K173445 FDA 510(k)
- FDA Product Code
- JWH FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3560 FDA 510(k)
- Regulation Number
- 888.3560 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Materialise TKA Guide System is a revolutionary knee replacement solution that offers unparalleled precision and accuracy in both soft tissue and bone regeneration. This innovative device has been thoroughly evaluated and certified by regulatory bodies worldwide, ensuring its compliance with the highest standards of quality and safety.
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 | K173445 | Class II | Active |
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Manufacturer
- Manufacturer
- Materialise NV
Sources (1)
- FDA 510(k) K173445 24 fields · synced Jul 9, 2026