The following data is part of a premarket notification filed by Medos International Sarl with the FDA for Expedium Spine System, Viper And Viper 2 Systems.
| Device ID | K160904 |
| 510k Number | K160904 |
| Device Name: | Expedium Spine System, VIPER And VIPER 2 Systems |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | MEDOS INTERNATIONAL SARL CHEMIN-BLANC 38 Le Locle, CH 2400 |
| Contact | Karen Sylvia |
| Correspondent | Mitch Ohiwa DEPUY SYNTHES SPINE 325 PARAMOUNT DRIVE Raynham, MA 02767 |
| Product Code | NKB |
| Subsequent Product Code | KWP |
| Subsequent Product Code | KWQ |
| Subsequent Product Code | MNH |
| Subsequent Product Code | MNI |
| Subsequent Product Code | OSH |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-04-01 |
| Decision Date | 2016-07-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10705034537368 | K160904 | 000 |
| 10705034537351 | K160904 | 000 |