K234119
- 510(k) number
- K234119
- Device name
- UniSpace® Stand-Alone C Cage
- Applicant
- Innosys Co., Ltd. KR
- Product code
- OVE — Intervertebral Fusion Device With Integrated Fixatio
- Decision date
- 2024-04-19
- Date received
- 2023-12-28
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 1.9 MB · U.S. public domain
Also available from FDA: K234119.pdf
Official FDA record: K234119
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.