The following data is part of a premarket notification filed by Nuvasive, Inc. with the FDA for Nuvasive Coroent No-profile System.
| Device ID | K112561 |
| 510k Number | K112561 |
| Device Name: | NUVASIVE COROENT NO-PROFILE SYSTEM |
| Classification | Intervertebral Fusion Device With Integrated Fixation, Lumbar |
| 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 | OVD |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-09-02 |
| Decision Date | 2012-03-13 |
| Summary: | summary |