K242195
- 510(k) number
- K242195
- Device name
- Gemini Cervical Fusion Cage System
- Applicant
- ZheJiang Decans Medical Devices Co., Ltd. CN
- Product code
- ODP — Intervertebral Fusion Device With Bone Graft, Cervic
- Decision date
- 2024-11-04
- Date received
- 2024-07-26
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K242195.pdf
Official FDA record: K242195
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.