The following data is part of a premarket notification filed by Medos International, Sarl with the FDA for Additional Viper Prime™ Screws With Fenestrations.
| Device ID | K171570 |
| 510k Number | K171570 |
| Device Name: | Additional VIPER PRIME™ Screws With Fenestrations |
| Classification | Thoracolumbosacral Pedicle Screw System |
| 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 | NKB |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-05-30 |
| Decision Date | 2017-08-31 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10705034509587 | K171570 | 000 |
| 10705034508962 | K171570 | 000 |
| 10705034508979 | K171570 | 000 |
| 10705034508986 | K171570 | 000 |
| 10705034508993 | K171570 | 000 |
| 10705034509006 | K171570 | 000 |
| 10705034509013 | K171570 | 000 |
| 10705034509167 | K171570 | 000 |
| 10705034509372 | K171570 | 000 |
| 10705034508955 | K171570 | 000 |