The following data is part of a premarket notification filed by Depuy Spine, Inc. with the FDA for Viper System, Expedium System.
| Device ID | K101993 |
| 510k Number | K101993 |
| Device Name: | VIPER SYSTEM, EXPEDIUM 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 | 2010-07-15 |
| Decision Date | 2010-12-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10705034122984 | K101993 | 000 |
| 10705034122724 | K101993 | 000 |
| 10705034122731 | K101993 | 000 |
| 10705034122748 | K101993 | 000 |
| 10705034122755 | K101993 | 000 |
| 10705034122762 | K101993 | 000 |
| 10705034122939 | K101993 | 000 |
| 10705034122946 | K101993 | 000 |
| 10705034122953 | K101993 | 000 |
| 10705034122960 | K101993 | 000 |
| 10705034122977 | K101993 | 000 |
| 10705034122717 | K101993 | 000 |