Stativ Knotted UHMWPE Suture Anchor
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K223889 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)
The Stativ Knotted UHMWPE Suture Anchor is a fixation device designed for soft tissue-to-bone repair. It consists of a soft anchor preloaded with non-absorbable UHMWPE sutures or tapes, which is mounted on an inserter with a handle.
This device is supplied sterile and is intended for single-use. It is classified as a nondegradable soft tissue fixation fastener and has received FDA 510(k) clearance.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Stativ® Knotted UHMWPE Suture Anchor (K223889) - Innolitics, Arthroscopy - Healthiummedtech, K223889 FDA 510 (k) - Stativ Knotted UHMWPE Suture Anchor
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K223889 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Healthium Medtech Limited
Sources (1)
- FDA 510(k) K223889 24 fields · synced Sep 25, 2026