The following data is part of a premarket notification filed by Nuvasive, Incorporated with the FDA for Coroent Xl-f System.
| Device ID | K140479 |
| 510k Number | K140479 |
| Device Name: | COROENT XL-F SYSTEM |
| Classification | Intervertebral Fusion Device With Integrated Fixation, Lumbar |
| Applicant | NUVASIVE, INCORPORATED 7475 LUSK BLVD San Diego, CA 92121 |
| Contact | Cynthia Adams |
| Correspondent | Cynthia Adams NUVASIVE, INCORPORATED 7475 LUSK BLVD San Diego, CA 92121 |
| Product Code | OVD |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-02-26 |
| Decision Date | 2014-07-28 |
| Summary: | summary |