The following data is part of a premarket notification filed by Onkos Surgical with the FDA for Eleos Limb Salvage System.
| Device ID | K211677 |
| 510k Number | K211677 |
| Device Name: | ELEOS Limb Salvage System |
| Classification | Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer |
| Applicant | Onkos Surgical 77 East Halsey Rd Parsippany, NJ 07054 |
| Contact | Matthew (matt) Vernak |
| Correspondent | Matthew (matt) Vernak Onkos Surgical 77 East Halsey Rd Parsippany, NJ 07054 |
| Product Code | KRO |
| Subsequent Product Code | JDI |
| Subsequent Product Code | JWH |
| Subsequent Product Code | LPH |
| Subsequent Product Code | LZO |
| CFR Regulation Number | 888.3510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-06-01 |
| Decision Date | 2021-07-28 |