The following data is part of a premarket notification filed by Nuvasive, Inc. with the FDA for Nuvasive Maxcess Light Guide.
| Device ID | K042034 |
| 510k Number | K042034 |
| Device Name: | NUVASIVE MAXCESS LIGHT GUIDE |
| Classification | Light, Surgical, Fiberoptic |
| Applicant | NUVASIVE, INC. 10065 OLD GROVE RD. San Diego, CA 92131 |
| Contact | Laetitia Cousin |
| Correspondent | Laetitia Cousin NUVASIVE, INC. 10065 OLD GROVE RD. San Diego, CA 92131 |
| Product Code | FST |
| CFR Regulation Number | 878.4580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-07-29 |
| Decision Date | 2004-10-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00887517285690 | K042034 | 000 |
| 00887517180513 | K042034 | 000 |
| 00887517128478 | K042034 | 000 |
| 00887517181848 | K042034 | 000 |
| 00887517196637 | K042034 | 000 |
| 00887517063434 | K042034 | 000 |
| 00887517074973 | K042034 | 000 |
| 00887517183323 | K042034 | 000 |
| 00887517183378 | K042034 | 000 |
| 00887517206084 | K042034 | 000 |
| 00887517206572 | K042034 | 000 |
| 00887517497222 | K042034 | 000 |
| 00887517184467 | K042034 | 000 |
| 00887517729071 | K042034 | 000 |
| 00887517075826 | K042034 | 000 |
| 00887517107305 | K042034 | 000 |
| 00887517118929 | K042034 | 000 |
| 00195377048752 | K042034 | 000 |