510(k) DEN210058
- Device
- ELEOSx™ Limb Salvage System
- Applicant
- Onkos Surgical
- 510(k) number
- DEN210058
- Product code
- QZZ
- Decision
- Unknown (DENG)
- Decision date
- 2024-04-05
- Date received
- 2021-12-30
- 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
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Matthew (Matt) Vernak
- Address
- 77 E. Halsey Rd. Parsippany NJ US 07054 07054
FDA Registration Numbers#
- 3013450937
- 3032003630
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code QZZ#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252920 | ELEOS™ Limb Salvage System with NanoCept® Technology | Onkos Surgical, Inc. | 2025-10-15 |