VIPER PRIME™ Screws With Fenestrations
Thoracolumbosacral Pedicle Screw System
Medos International, SARL
The following data is part of a premarket notification filed by Medos International, Sarl with the FDA for Viper Prime™ Screws With Fenestrations.
Pre-market Notification Details
| Device ID | K170543 |
| 510k Number | K170543 |
| Device Name: | 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 |
| Subsequent Product Code | KWP |
| Subsequent Product Code | KWQ |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-02-24 |
| Decision Date | 2017-05-04 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10705034509648 | K170543 | 000 |
| 10705034509181 | K170543 | 000 |
| 10705034509198 | K170543 | 000 |
| 10705034509204 | K170543 | 000 |
| 10705034509211 | K170543 | 000 |
| 10705034509228 | K170543 | 000 |
| 10705034509389 | K170543 | 000 |
| 10705034509396 | K170543 | 000 |
| 10705034509402 | K170543 | 000 |
| 10705034509419 | K170543 | 000 |
| 10705034509426 | K170543 | 000 |
| 10705034509433 | K170543 | 000 |
| 10705034509594 | K170543 | 000 |
| 10705034509600 | K170543 | 000 |
| 10705034509617 | K170543 | 000 |
| 10705034509624 | K170543 | 000 |
| 10705034509631 | K170543 | 000 |
| 10705034509174 | K170543 | 000 |
Trademark Results [VIPER PRIME]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 VIPER PRIME 86819099 5464979 Live/Registered |
DePuy Synthes, Inc. 2015-11-13 |
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