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 |