The following data is part of a premarket notification filed by Onkos Surgical, Inc. with the FDA for Eleos Limb Salvage System.
Device ID | K161520 |
510k Number | K161520 |
Device Name: | ELEOS Limb Salvage System |
Classification | Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer |
Applicant | Onkos Surgical, Inc. 77 East Halsey Road Parsippany, NJ 07054 |
Contact | Jan Triani |
Correspondent | Jan Triani Onkos Surgical, Inc. 77 East Halsey Road 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 | 2016-06-02 |
Decision Date | 2016-10-28 |
Summary: | summary |