The following data is part of a premarket notification filed by Medos International Sarl with the FDA for Expedium Spine System.
| Device ID | K101070 |
| 510k Number | K101070 |
| Device Name: | EXPEDIUM SPINE SYSTEM |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | MEDOS INTERNATIONAL SARL 325 Paramount Drive Raynham, MA 02767 |
| Contact | Daphney Germain |
| Correspondent | Daphney Germain 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 |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-04-16 |
| Decision Date | 2010-08-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10705034343303 | K101070 | 000 |
| 10705034343280 | K101070 | 000 |
| 10705034032115 | K101070 | 000 |