The following data is part of a premarket notification filed by Nuvasive, Inc. with the FDA for Nuvasive Spherx Ii System.
| Device ID | K061778 |
| 510k Number | K061778 |
| Device Name: | NUVASIVE SPHERX II SYSTEM |
| Classification | Orthosis, Spondylolisthesis Spinal Fixation |
| Applicant | NUVASIVE, INC. 4545 TOWNE CENTRE COURT San Diego, CA 92121 |
| Contact | Laetitia Cousin |
| Correspondent | Laetitia Cousin NUVASIVE, INC. 4545 TOWNE CENTRE COURT San Diego, CA 92121 |
| Product Code | MNH |
| Subsequent Product Code | KWP |
| Subsequent Product Code | KWQ |
| 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 | 2006-06-26 |
| Decision Date | 2006-07-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00887517432650 | K061778 | 000 |
| 00887517430809 | K061778 | 000 |