Gemini Medical Cage System
FDA 510(k) K242267 · ZheJiang Decans Medical Devices Co., Ltd.
510(k) numberK242267
Submission
- Device name
- Gemini Medical Cage System
- Applicant
- ZheJiang Decans Medical Devices Co., Ltd.
Jiaxing, CN - Received
- August 1, 2024
- Decision date
- October 8, 2024
- 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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|---|---|---|---|
| K261049 | Scala® TLMAX · Traditional | Spineart SA | 08/20/2026SE |
| K261430 | TruLift Expandable SystemMAX · Traditional | Life Spine, Inc. | 07/28/2026SE |
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| K261020 | Symmetrix L Spinal SystemMAX · Traditional | Medtronic Sofamor Danek USA, Inc. | 07/14/2026SE |
| K253420 | Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…MAX · Traditional | SeaSpine Orthopedics Corporation | 07/01/2026SE |
| K253151 | Fule Interbody Fusion Cage SystemMAX · Traditional | Beijing Fule Science & Technology Development… | 06/15/2026SE |
| K261159 | Exceed® Biplanar Expandable Interbody SystemMAX · Traditional | Spine Wave, Inc. | 05/29/2026SE |
| K253894 | BMD Titanium Spinal Fusion SystemMAX · Traditional | Global Biomedica s.r.o. | 05/28/2026SE |
| K260506 | Ventana® P/T Lumbar Interbody SystemMAX · Traditional | Spinal Elements, Inc. | 05/15/2026SE |
| K260837 | VersaLift Expandable SystemMAX · Traditional | Life Spine, Inc. | 05/12/2026SE |
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| K253046 | HERA Interlocking Intramedullary Nailing SystemHSB · Traditional | 06/16/2026SE |
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| K253130 | Dione PEEK Screw SystemMBI · Traditional | 05/27/2026SE |
| K252930 | AQUA Laminoplasty SystemsNQW · Traditional | 05/27/2026SE |
| K252776 | ARIES Anterior Cervical Plate SystemsKWQ · Traditional | 05/14/2026SE |
| K252542 | LEO Spinal SystemNKB · Traditional | 04/29/2026SE |
| K253213 | SAGI Cervical Cage SystemOVE · Traditional | 04/20/2026SE |
| K252774 | Uni-C Cervical Cage SystemOVE · Traditional | 04/15/2026SE |
| K243665 | Crius PEEK Suture Anchor System (Thread-Fix Anchor); Crius PEEK Suture Anchor System…MBI · Traditional | 01/31/2025SE |
| K242195 | Gemini Cervical Fusion Cage SystemODP · Traditional | 11/04/2024SE |
Questions and answers
When was Gemini Medical Cage System cleared by the FDA?
Gemini Medical Cage System (K242267) received a 510(k) decision of Substantially Equivalent on October 8, 2024, 68 days after the submission was received.
What is the product code of K242267?
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.