The following data is part of a premarket notification filed by Nuvasive, Incorporated with the FDA for Nuvasive Alif Buttress Plate System.
| Device ID | K143065 |
| 510k Number | K143065 |
| Device Name: | NuVasive ALIF Buttress Plate System |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | NUVASIVE, INCORPORATED 7475 LUSK BOULEVARD San Diego, CA 92121 |
| Contact | Michelle Cheung |
| Correspondent | Michelle Cheung NUVASIVE, INCORPORATED 7475 LUSK BOULEVARD San Diego, CA 92121 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-10-24 |
| Decision Date | 2015-01-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00887517728029 | K143065 | 000 |
| 00887517728012 | K143065 | 000 |
| 00887517728005 | K143065 | 000 |
| 00887517727992 | K143065 | 000 |