The following data is part of a premarket notification filed by Depuy Spine, Inc. with the FDA for Expedium System, Viper System.
| Device ID | K110216 |
| 510k Number | K110216 |
| Device Name: | EXPEDIUM SYSTEM, VIPER SYSTEM |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | DEPUY SPINE, INC. 325 PARAMOUNT DR. Raynham, MA 02767 |
| Contact | Eugene Bang |
| Correspondent | Eugene Bang 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 | 2011-01-25 |
| Decision Date | 2011-04-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10705034282039 | K110216 | 000 |
| 10705034281636 | K110216 | 000 |
| 10705034281629 | K110216 | 000 |
| 10705034281612 | K110216 | 000 |
| 10705034281605 | K110216 | 000 |
| 10705034281452 | K110216 | 000 |
| 10705034281445 | K110216 | 000 |
| 10705034281438 | K110216 | 000 |
| 10705034281421 | K110216 | 000 |
| 10705034281414 | K110216 | 000 |
| 10705034281643 | K110216 | 000 |
| 10705034281650 | K110216 | 000 |
| 10705034282022 | K110216 | 000 |
| 10705034282015 | K110216 | 000 |
| 10705034282008 | K110216 | 000 |
| 10705034281995 | K110216 | 000 |
| 10705034281858 | K110216 | 000 |
| 10705034281841 | K110216 | 000 |
| 10705034281834 | K110216 | 000 |
| 10705034281827 | K110216 | 000 |
| 10705034281810 | K110216 | 000 |
| 10705034281407 | K110216 | 000 |