ELEOSx™ Limb Salvage System
FDA 510(k) clearance DEN210058 · decided 2024-04-05
Clearance details
- K-number
- DEN210058
- Device name
- ELEOSx™ Limb Salvage System
- Applicant
- Onkos Surgical
- Decision
- Unknown
- Date received
- 2021-12-30
- Decision date
- 2024-04-05
- Days to decision
- 827 days
- Clearance type
- Direct
- Product code
- QZZ
- Device class
- 2
- Regulation number
- 888.3900
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Parsippany, NJ, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| ELEOS™ with NanoCept® Technology Limb Salvage System (K253066) | Onkos Surgical, Inc. | 2026-06-08 |
| ELEOS™ Limb Salvage System with NanoCept® Technology (K252920) | Onkos Surgical, Inc. | 2025-10-15 |
Recalls involving this device
No recalls on record reference this clearance.