ELEOS™ with NanoCept® Technology Limb Salvage System
FDA 510(k) clearance K253066 · decided 2026-06-08
Clearance details
- K-number
- K253066
- Device name
- ELEOS™ with NanoCept® Technology Limb Salvage System
- Applicant
- Onkos Surgical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2025-09-22
- Decision date
- 2026-06-08
- Days to decision
- 259 days
- Clearance type
- Traditional
- 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™ Limb Salvage System with NanoCept® Technology (K252920) | Onkos Surgical, Inc. | 2025-10-15 |
| ELEOSx™ Limb Salvage System (DEN210058) | Onkos Surgical | 2024-04-05 |
Recalls involving this device
No recalls on record reference this clearance.