K242483
- 510(k) number
- K242483
- Device name
- Genesys Spine AIS-C II Cervical Interbody Fusion System
- Applicant
- Genesys Spine TX · US
- Product code
- OVE — Intervertebral Fusion Device With Integrated Fixatio
- Decision date
- 2025-02-07
- Date received
- 2024-08-21
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 2.8 MB · U.S. public domain
Also available from FDA: K242483.pdf
Official FDA record: K242483
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.