Self- Compressive Screw
FDA 510(k)Class II (US FDA 510(k))
by Neosteo
Identifiers
- 510(k) Number
- K153182 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)
Self-Compressive Screw is a metallic bone fixation fastener used in orthopedic surgery. Device consists of titanium alloy screws available in various diameters and lengths.
Self-Compressive Screw is supplied as a metallic bone fixation fastener for use in orthopedic surgery. It is available in several diameters and lengths and is indicated for the fixation of bone fractures and bone reconstruction in the hand and forefoot surgery.
Frequently asked questions
What is the Self-Compressive Screw used for?
The Self-Compressive Screw is a metallic bone fixation fastener used in orthopedic surgery for the fixation of bone fractures and bone reconstruction, specifically indicated for hand and forefoot procedures.
What material is the Self-Compressive Screw made of and how is it supplied?
The Self-Compressive Screw is made of titanium alloy and is supplied as a metallic bone fixation fastener in various diameters and lengths for orthopedic surgical use.
Is the Self-Compressive Screw intended for single-use or reuse?
The device data does not specify whether the Self-Compressive Screw is intended for single-use or reuse; therefore, this information cannot be determined from the provided details.
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: SELF-COMPRESSIVE SCREW (K131471) — FDA 510 (k) | Innolitics, SELF- COMPRESSIVE SCREW (K153182) — FDA 510(k) | Innolitics, Snap-Off Self-Compressive Screw by NEOSTEO | FDA 510 (k) Summary, PDF Neosteo
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K153182 | Class II | Active |
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Manufacturer
- Manufacturer
- Neosteo
Sources (1)
- FDA 510(k) K153182 24 fields · synced Sep 24, 2026