The following data is part of a premarket notification filed by Nuvasive, Inc. with the FDA for Affix Spinous Process Plate System.
| Device ID | K131238 |
| 510k Number | K131238 |
| Device Name: | AFFIX SPINOUS PROCESS PLATE SYSTEM |
| Classification | Spinous Process Plate |
| Applicant | NUVASIVE, INC. 7475 LUSK BLVD San Diego, CA 92121 |
| Contact | Sheila Bruschi |
| Correspondent | Sheila Bruschi NUVASIVE, INC. 7475 LUSK BLVD San Diego, CA 92121 |
| Product Code | PEK |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-05-01 |
| Decision Date | 2013-07-02 |
| Summary: | summary |