The following data is part of a premarket notification filed by Medos International, Sarl with the FDA for Viper Prime Navigated Inserter.
| Device ID | K170937 |
| 510k Number | K170937 |
| Device Name: | VIPER PRIME Navigated Inserter |
| Classification | Orthopedic Stereotaxic Instrument |
| Applicant | Medos International, SARL Chemin-Blanc 38 Le Locle, CH 2400 |
| Contact | Karen Sylvia |
| Correspondent | Laura Bleyendaal DePuy Synthes 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 | 2017-03-30 |
| Decision Date | 2017-09-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10705034507828 | K170937 | 000 |