Double Medical Cage System
FDA 510(k) K172828 · Double Medical Technology, Inc.
510(k) numberK172828
Submission
- Device name
- Double Medical Cage System
- Applicant
- Double Medical Technology, Inc.
Xiamen, CN - Received
- September 18, 2017
- Decision date
- February 1, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MAX – Intervertebral Fusion Device With Bone Graft, Lumbar
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3080
- Specialty
- Orthopedic
- Implant
- Yes
Intended to stabilize spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.
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Questions and answers
When was Double Medical Cage System cleared by the FDA?
Double Medical Cage System (K172828) received a 510(k) decision of Substantially Equivalent on February 1, 2018, 136 days after the submission was received.
What is the product code of K172828?
The FDA product code is MAX – Intervertebral Fusion Device With Bone Graft, Lumbar, a Class II (moderate risk) device regulated under 21 CFR 888.3080.