K232790
- 510(k) number
- K232790
- Device name
- KONG®-TL VBR System and KONG® C VBR System
- Applicant
- Icotec AG CH
- Product code
- MQP — Spinal Vertebral Body Replacement Device
- Decision date
- 2024-04-04
- Date received
- 2023-09-11
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
510(k) Summary (official FDA PDF): K232790.pdf
Official FDA record: K232790
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.