Identifiers
- 510(k) Number
- K151601 FDA 510(k)
- FDA Product Code
- MBI FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3040 FDA 510(k)
- Regulation Number
- 888.3040 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
At Xiros, Ltd., we are proud to introduce the SECURE-LOOP, a groundbreaking orthopedic medical device designed to provide unparalleled stability and security for implantable devices. Our team of expert engineers has worked tirelessly to craft this revolutionary product, leveraging cutting-edge technology and innovative materials to create a truly game-changing solution for healthcare professionals and patients alike.
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 | K151601 | Class II | Active |
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Manufacturer
- Manufacturer
- Xiros Ltd
- FDA Applicant
- Xiros, Ltd.
Sources (1)
- FDA 510(k) K151601 24 fields · synced Jul 18, 2026