The following data is part of a premarket notification filed by Nuvasive, Incorporated with the FDA for Coroent Thoracolumbar Implants.
| Device ID | K140659 |
| 510k Number | K140659 |
| Device Name: | COROENT THORACOLUMBAR IMPLANTS |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | NUVASIVE, INCORPORATED 7475 LUSK BLVD San Diego, CA 92121 |
| Contact | Olga Lewis |
| Correspondent | Olga Lewis NUVASIVE, INCORPORATED 7475 LUSK BLVD San Diego, CA 92121 |
| Product Code | MAX |
| Subsequent Product Code | MQP |
| Subsequent Product Code | PHM |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-03-14 |
| Decision Date | 2014-06-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00887517340597 | K140659 | 000 |
| 00887517338563 | K140659 | 000 |
| 00887517342867 | K140659 | 000 |
| 00887517342850 | K140659 | 000 |
| 00887517340573 | K140659 | 000 |
| 00887517338549 | K140659 | 000 |
| 00887517336637 | K140659 | 000 |
| 00887517336613 | K140659 | 000 |