K233594
- 510(k) number
- K233594
- Device name
- Genesys Spine 3DP AIS-C II Cervical Interbody System
- Applicant
- Genesys Spine TX · US
- Product code
- OVE — Intervertebral Fusion Device With Integrated Fixatio
- Decision date
- 2023-12-13
- Date received
- 2023-11-08
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 1.1 MB · U.S. public domain
Also available from FDA: K233594.pdf
Official FDA record: K233594
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.