The following data is part of a premarket notification filed by Nuvasive, Incorporated with the FDA for Nuvasive Coroent Thoracolumbar Implants.
| Device ID | K150994 |
| 510k Number | K150994 |
| Device Name: | NuVasive CoRoent Thoracolumbar Implants |
| Classification | Intervertebral Fusion Device With Bone Graft, Thoracic |
| 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 | PHM |
| Subsequent Product Code | MAX |
| Subsequent Product Code | MQP |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-04-15 |
| Decision Date | 2015-06-17 |
| Summary: | summary |