Identifiers
- 510(k) Number
- K143752 FDA 510(k)
- FDA Product Code
- OLO FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 882.4560 FDA 510(k)
- Regulation Number
- 882.4560 FDA 510(k)
- Advisory Committee
- Neurology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Total Knee Application (TKA) is a minimally invasive surgical device designed to treat knee disorders, providing durable and effective treatment options for patients. It features advanced technology and precision engineering, ensuring optimal outcomes and patient satisfaction.
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 | K143752 | Class II | Active |
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Manufacturer
- Manufacturer
- MAKO Surgical Corp.
Sources (1)
- FDA 510(k) K143752 24 fields · synced Jul 5, 2026