The following data is part of a premarket notification filed by Depuy Spine, Inc. with the FDA for Viper System.
| Device ID | K121020 |
| 510k Number | K121020 |
| Device Name: | VIPER SYSTEM |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | DEPUY SPINE, INC. 325 PARAMOUNT DR. Raynham, MA 02767 |
| Contact | Kirsten Lehmuller |
| Correspondent | Kirsten Lehmuller DEPUY SPINE, INC. 325 PARAMOUNT DR. Raynham, MA 02767 |
| Product Code | NKB |
| Subsequent Product Code | KWP |
| Subsequent Product Code | MNH |
| Subsequent Product Code | MNI |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-04-04 |
| Decision Date | 2012-05-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10705034346731 | K121020 | 000 |
| 10705034346540 | K121020 | 000 |
| 10705034346557 | K121020 | 000 |
| 10705034346564 | K121020 | 000 |
| 10705034346663 | K121020 | 000 |
| 10705034346670 | K121020 | 000 |
| 10705034346687 | K121020 | 000 |
| 10705034346694 | K121020 | 000 |
| 10705034346700 | K121020 | 000 |
| 10705034346717 | K121020 | 000 |
| 10705034346724 | K121020 | 000 |
| 10705034346533 | K121020 | 000 |