Stabilization Screw
FDA 510(k)Class II (US FDA 510(k))
by In2Bones SAS
Identifiers
- 510(k) Number
- K131920 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)
A stabilization screw is a bone fixation device used in orthopedic applications. It is designed to provide structural support and stabilization in bone repair procedures.
This device is supplied non-sterile and is intended for reusable use. It has received FDA 510(k) clearance under product code HWC, with a substantially equivalent determination made on May 1, 2014.
Frequently asked questions
What is the STABILIZATION SCREW used for?
The STABILIZATION SCREW is a bone fixation device designed to provide structural support and stabilization in orthopedic bone repair procedures. It helps maintain proper alignment and stability during the healing process.
How is the STABILIZATION SCREW supplied and can it be reused?
The STABILIZATION SCREW is supplied non-sterile and is intended for reusable use. This means it can be cleaned and sterilized for multiple procedures according to standard medical device reprocessing protocols.
What regulatory approvals does the STABILIZATION SCREW have?
The STABILIZATION SCREW has received FDA 510(k) clearance under product code HWC with a substantially equivalent determination made on May 1, 2014. This clearance indicates it meets the necessary safety and effectiveness requirements for market distribution.
What sizes and models of the STABILIZATION SCREW are available?
The device data does not specify available sizes or models for the STABILIZATION SCREW. For detailed information regarding available sizes, configurations, or specific models, please contact the manufacturer directly or refer to the product documentation.
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: STABILIZATION SCREW (K131920) — FDA 510 (k) | Innolitics, K131920 - Screw, Fixation, Bone FDA 510 (k) APPLICATION FOR IN2BONES SAS, FDA 510(k) Applications Submitted by In2Bones SAS
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K131920 | Class II | Active |
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Manufacturer
- Manufacturer
- In2Bones SAS
Sources (1)
- FDA 510(k) K131920 24 fields · synced Sep 27, 2026