510(k) DEN210058
DEN210058 is an FDA 510(k) premarket notification submitted by Onkos Surgical for the device "ELEOSx Limb Salvage System". The FDA issued a decision of De Novo Granted on April 5, 2024. The device falls under product code QZZ (Limb And Joint Salvage Device With Coating For Bacteria Reduction), a Class II device regulated under 21 CFR 888.3900. Onkos Surgical has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- April 5, 2024
- Date Received
- December 30, 2021
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Limb And Joint Salvage Device With Coating For Bacteria Reduction
- Device Class
- Class II
- Regulation Number
- 888.3900
- Review Panel
- OR
- Submission Type
A limb and joint salvage device with quaternary ammonium compound coating is a metallic implant with or without polymer bearing for bone and joint replacement. Implants are for resection and replacement of an extremity bone (including the entire bone, epiphyseal bone, metaphyseal bone, or diaphyseal bone), or an extremity bone and the surrounding joint(s) in a skeletally mature patient. The device includes a quaternary ammonium compound coating that is covalently bonded to the device. Where applied, the coating is intended to reduce microbial contamination on the surface of the device prior to implantation. The device does not contain antimicrobial agents that act within or on the body and this device type does not include combination products.