The following data is part of a premarket notification filed by Nuvasive, Inc. with the FDA for Ap Expandable Xlif System.
| Device ID | K140162 |
| 510k Number | K140162 |
| Device Name: | AP EXPANDABLE XLIF SYSTEM |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | NUVASIVE, INC. 7475 LUSK BLVD San Diego, CA 92121 |
| Contact | Cynthia Adams |
| Correspondent | Cynthia Adams NUVASIVE, INC. 7475 LUSK BLVD San Diego, CA 92121 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-01-22 |
| Decision Date | 2014-07-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00887517454072 | K140162 | 000 |
| 00887517184740 | K140162 | 000 |
| 00887517184757 | K140162 | 000 |
| 00887517184764 | K140162 | 000 |
| 00887517451569 | K140162 | 000 |
| 00887517451576 | K140162 | 000 |
| 00887517451583 | K140162 | 000 |
| 00887517451590 | K140162 | 000 |
| 00887517451903 | K140162 | 000 |
| 00887517453686 | K140162 | 000 |
| 00887517453693 | K140162 | 000 |
| 00887517454003 | K140162 | 000 |
| 00887517454010 | K140162 | 000 |
| 00887517454027 | K140162 | 000 |
| 00887517454034 | K140162 | 000 |
| 00887517454041 | K140162 | 000 |
| 00887517454058 | K140162 | 000 |
| 00887517454065 | K140162 | 000 |
| 00887517211019 | K140162 | 000 |