Cannulated Fasteners and Nuts
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K210754 FDA 510(k)
- FDA Product Code
- HWC 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 Cannulated Fasteners and Nuts are orthopedic devices used for reduction and stabilization of fractures or inter-osseous distances. They consist of cannulated fasteners in various lengths and diameters, made from Stainless Steel per ASTM F138. The devices are part of the Cannulated Fastener System, which includes options such as full thread, partial thread, and variable thread.
The Cannulated Fasteners and Nuts are provided non-sterile and are available in different sizes, including 7.0mm and 8.0mm. They have received FDA 510K authorization, with a clearance type of Special and a decision code of SESE. The devices are manufactured by OsteoCentric Technologies and have a product code of HWC.
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: Cannulated Fastener System | Osteocentric, CURRENT PRODUCTS | Osteocentric, OsteoCentric Technologies Cannulated Fasteners and Nuts (K242691) — FDA ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K210754 | Class II | Active |
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Manufacturer
- Manufacturer
- OsteoCentric Technologies
Sources (1)
- FDA 510(k) K210754 24 fields · synced Sep 28, 2026