The following data is part of a premarket notification filed by Medos International Sarl with the FDA for Expedium Spine System.
| Device ID | K130877 |
| 510k Number | K130877 |
| Device Name: | EXPEDIUM SPINE SYSTEM |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | MEDOS INTERNATIONAL SARL 325 Paramount Drive Raynham, MA 02767 |
| Contact | Kirsten Lehmuller |
| Correspondent | Kirsten Lehmuller MEDOS INTERNATIONAL SARL 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 | 2013-03-29 |
| Decision Date | 2013-06-20 |
| Summary: | summary |