Gemini Cervical Fusion Cage System
by ZheJiang Decans Medical Devices Co., Ltd.
510(k) K242195
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK242195 | Date4 Nov 2024 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- ODP
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.3080
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Gemini Cervical Fusion Cage System is an intervertebral body fusion device designed for spinal stabilization in the cervical spine. It consists of cages intended to facilitate bony fusion between adjacent vertebrae, restoring structural integrity and promoting long-term spinal alignment. The system is classified under 21 CFR 888.3080 as an intervertebral body fusion device, suitable for surgical applications where segmental support is required. Its modular design allows for customization to match specific anatomical requirements, enhancing procedural flexibility.
The system is supplied sterile and intended for single-use, adhering to FDA 510(k) clearance (K242195) under the Orthopedic (OR) advisory committee. It is distributed in sterile packaging, requiring surgical implantation by trained professionals in an operating room setting. Compatibility with MRI is not specified, and sizes are determined by the manufacturer’s specifications for cervical spine applications. Storage must follow sterile field protocols to maintain integrity until use.
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Questions
AI-generated answers, 1 Oct 2026
What is the Gemini Cervical Fusion Cage System used for?
The Gemini Cervical Fusion Cage System is designed for spinal stabilization in the cervical spine. It facilitates bony fusion between adjacent vertebrae, restoring structural integrity and promoting long-term spinal alignment. This is particularly useful in surgical procedures where segmental support is required to maintain proper cervical spine function.
How is the Gemini Cervical Fusion Cage System supplied and prepared for use?
The system is supplied sterile in its packaging, ensuring readiness for immediate surgical use. It is intended for single-use only, meaning each sterile package is meant to be opened once and used in a single procedure. The sterile field protocols must be followed to preserve the integrity of the device until implantation by trained professionals in an operating room setting.
Is the Gemini Cervical Fusion Cage System reusable or single-use?
The Gemini Cervical Fusion Cage System is explicitly designed for single-use only. This classification aligns with FDA guidelines and ensures patient safety by preventing cross-contamination and maintaining sterility. Reuse is not recommended or supported by the manufacturer.
What sizes are available for the Gemini Cervical Fusion Cage System?
The sizes for the Gemini Cervical Fusion Cage System are determined by the manufacturer’s specifications tailored for cervical spine applications. The modular design allows for customization to fit specific anatomical requirements, ensuring flexibility during surgical procedures. Exact dimensions or model references should be confirmed with the manufacturer or product documentation.
How should the Gemini Cervical Fusion Cage System be stored before use?
The system must be stored according to sterile field protocols to maintain its integrity until use. This includes keeping the sterile packaging unopened and protected from contamination, moisture, and physical damage. Proper storage conditions ensure the device remains sterile and functional for its intended single-use application in the operating room.