The following data is part of a premarket notification filed by Medos International Sarl with the FDA for Viper And Expedium Navigated Instruments.
| Device ID | K120867 |
| 510k Number | K120867 |
| Device Name: | VIPER AND EXPEDIUM NAVIGATED INSTRUMENTS |
| Classification | Orthopedic Stereotaxic Instrument |
| Applicant | MEDOS INTERNATIONAL SARL 325 Paramount Drive Raynham, MA 02767 |
| Contact | Laura Bleyendaal |
| Correspondent | Laura Bleyendaal MEDOS INTERNATIONAL SARL 325 Paramount Drive Raynham, MA 02767 |
| Product Code | OLO |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-03-22 |
| Decision Date | 2012-09-20 |
| Summary: | summary |