The following data is part of a premarket notification filed by Onkos Surgical with the FDA for Eleos Limb Salvage System Featuring Biogrip.
| Device ID | K203090 |
| 510k Number | K203090 |
| Device Name: | ELEOS Limb Salvage System Featuring BIOGRIP |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| 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 | JDI |
| Subsequent Product Code | JWH |
| Subsequent Product Code | KRO |
| Subsequent Product Code | LPH |
| Subsequent Product Code | LZO |
| CFR Regulation Number | 888.3350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-10-13 |
| Decision Date | 2020-12-11 |