Ascension Cannulated Screw System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K092440 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 Ascension Cannulated Screw System is an orthopedic device consisting of metallic cannulated screws that are self‑drilling and self‑tapping. The system is intended for use in surgical procedures requiring fixation of bone fragments or implants.
The system is supplied in a range of diameters and lengths and is manufactured from stainless steel or titanium. It includes accompanying washers, guide wires and other orthopedic surgical accessories. The device has received FDA 510(k) traditional clearance (K092440) and is classified as product code 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: ASCENSION CANNULATED SCREW SYSTEM (K092440) — FDA 510 (k) - Innolitics, ASCENSION CANNULATED SCREW SYSTEM 510(k) K092440 - FDA.report, PDF o V -[ 0 - Food and Drug Administration, Ascension Cannulated Screw System - Beudamed
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K092440 | Class II | Active |
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Manufacturer
- Manufacturer
- Ascension Orthopedics, Inc.
Sources (1)
- FDA 510(k) K092440 24 fields · synced Sep 25, 2026