The following data is part of a premarket notification filed by Nuvasive, Inc. with the FDA for Affix(r) Next Gen Spinous Process Plate System.
| Device ID | K133052 |
| 510k Number | K133052 |
| Device Name: | AFFIX(R) NEXT GEN SPINOUS PROCESS PLATE SYSTEM |
| Classification | Spinous Process Plate |
| Applicant | NUVASIVE, INC. 7475 LUSK BLVD San Diego, CA 92121 |
| Contact | Olga Lewis |
| Correspondent | Olga Lewis 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 | 2013-09-27 |
| Decision Date | 2013-12-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00887517257772 | K133052 | 000 |
| 00887517257758 | K133052 | 000 |
| 00887517257734 | K133052 | 000 |
| 00887517790040 | K133052 | 000 |
| 00887517790026 | K133052 | 000 |
| 00887517790002 | K133052 | 000 |