Identifiers
- 510(k) Number
- K172828 FDA 510(k)
- FDA Product Code
- MAX FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3080 FDA 510(k)
- Regulation Number
- 888.3080 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Double Medical Cage System is an interbody fusion device indicated for use in patients with degenerative disc disease (DDD) at one or two levels from L2 to L5. It is designed to be used with supplemental fixation for spinal conditions requiring interbody fusion.
The system is supplied as a single-use device and requires proper storage conditions. It has received FDA 510(k) clearance with the product code MAX and is intended for use in orthopedic procedures.
Frequently asked questions
What is the Double Medical Cage System used for?
The Double Medical Cage System is an interbody fusion device indicated for patients with degenerative disc disease (DDD) at one or two levels from L2 to L5, designed to be used with supplemental fixation for spinal fusion procedures.
Is the Double Medical Cage System reusable or single-use?
The Double Medical Cage System is supplied as a single-use device and should not be reused on multiple patients. Proper storage conditions must be maintained before use to ensure device integrity.
What regulatory clearance has the Double Medical Cage System received?
The Double Medical Cage System has received FDA 510(k) clearance with the product code MAX, determined to be substantially equivalent to predicate devices for interbody fusion in orthopedic procedures.
How is the Double Medical Cage System supplied?
The system is supplied as a single-use device requiring proper storage conditions. The specific packaging and sterilization details are not provided in the available device information.
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: Home - Double Medical, Products - Double Medical, Double Medical Cage System (K172828) — FDA 510(k) | Innolitics, K172828 FDA 510 (k) - Double Medical Cage System
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K172828 | Class II | Active |
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Manufacturer
- Manufacturer
- Double Medical Technology Inc.
- FDA Applicant
- Double Medical Technology, Inc.
Sources (1)
- FDA 510(k) K172828 24 fields · synced Sep 28, 2026