The following data is part of a premarket notification filed by Depuy Spine, Inc. with the FDA for Viper 2 System.
| Device ID | K090648 |
| 510k Number | K090648 |
| Device Name: | VIPER 2 SYSTEM |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | DEPUY SPINE, INC. 325 PARAMOUNT DR. Raynham, MA 02767 |
| Contact | Frank Jurczak |
| Correspondent | Frank Jurczak DEPUY SPINE, INC. 325 PARAMOUNT DR. Raynham, MA 02767 |
| Product Code | NKB |
| Subsequent Product Code | KWP |
| Subsequent Product Code | KWQ |
| 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 | 2009-03-11 |
| Decision Date | 2009-06-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10705034295282 | K090648 | 000 |
| 10705034295275 | K090648 | 000 |
| 10705034295268 | K090648 | 000 |
| 10705034295251 | K090648 | 000 |
| 10705034295244 | K090648 | 000 |
| 10705034295237 | K090648 | 000 |
| 10705034182537 | K090648 | 000 |