510(k) K252920
- Device
- ELEOS™ Limb Salvage System with NanoCept® Technology
- Applicant
- Onkos Surgical, Inc.
- 510(k) number
- K252920
- Product code
- QZZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-10-15
- Date received
- 2025-09-12
- Regulation
- 888.3900
- Classification name
- Limb And Joint Salvage Device With Coating For Bacteria Reduction
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Arley Perez
- Address
- 77 E. Halsey Rd. Parsippany NJ US 07054 07054
FDA Registration Numbers#
- 3013450937
- 3032003630
Source Documents#
Other 510(k) Records For Product Code QZZ#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| DEN210058 | ELEOSx™ Limb Salvage System | Onkos Surgical | 2024-04-05 |