The following data is part of a premarket notification filed by Nuvasive, Inc. with the FDA for Spinous Process Plate System.
| Device ID | K073278 |
| 510k Number | K073278 |
| Device Name: | SPINOUS PROCESS PLATE SYSTEM |
| Classification | Appliance, Fixation, Spinal Interlaminal |
| 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 | KWP |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-11-21 |
| Decision Date | 2008-03-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00887517062369 | K073278 | 000 |
| 00887517063687 | K073278 | 000 |
| 00887517063694 | K073278 | 000 |
| 00887517058676 | K073278 | 000 |
| 00887517058683 | K073278 | 000 |
| 00887517059161 | K073278 | 000 |
| 00887517059178 | K073278 | 000 |
| 00887517059185 | K073278 | 000 |
| 00887517062338 | K073278 | 000 |
| 00887517062345 | K073278 | 000 |
| 00887517062352 | K073278 | 000 |
| 00887517063670 | K073278 | 000 |