DEN210058
- 510(k) number
- DEN210058
- Device name
- ELEOSx Limb Salvage System
- Applicant
- Onkos Surgical NJ · US
- Product code
- QZZ — Limb And Joint Salvage Device With Coating For Bacte
- Decision date
- 2024-04-05
- Date received
- 2021-12-30
- Decision
- Unknown
- Clearance type
- Direct
- Advisory committee
- Orthopedic
Official FDA record: DEN210058
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.