The following data is part of a premarket notification filed by Depuy Spine, A Johnson & Johnson Company with the FDA for Expedium, Viper. Viper 2 Spine System.
| Device ID | K131802 |
| 510k Number | K131802 |
| Device Name: | EXPEDIUM, VIPER. VIPER 2 SPINE SYSTEM |
| Classification | Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis |
| Applicant | DEPUY SPINE, A JOHNSON & JOHNSON COMPANY 325 Paramount Drive Raynham, MA 02767 |
| Contact | Kirsten Lehmuller |
| Correspondent | Kirsten Lehmuller DEPUY SPINE, A JOHNSON & JOHNSON COMPANY 325 Paramount Drive Raynham, MA 02767 |
| Product Code | OSH |
| Subsequent Product Code | KWP |
| Subsequent Product Code | KWQ |
| Subsequent Product Code | MNH |
| Subsequent Product Code | MNI |
| Subsequent Product Code | NKB |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-06-19 |
| Decision Date | 2013-09-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10705034270333 | K131802 | 000 |
| 10705034270302 | K131802 | 000 |
| 10705034270258 | K131802 | 000 |
| 10705034270227 | K131802 | 000 |
| 10705034270197 | K131802 | 000 |
| 10705034270166 | K131802 | 000 |
| 10705034270135 | K131802 | 000 |
| 10705034270104 | K131802 | 000 |