The following data is part of a premarket notification filed by Nuvasive, Incorporated with the FDA for Nuvasive Cohere Thoracolumbar Interbody System.
| Device ID | K181860 |
| 510k Number | K181860 |
| Device Name: | NuVasive Cohere Thoracolumbar Interbody System |
| 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 |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-07-12 |
| Decision Date | 2018-10-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00195377029522 | K181860 | 000 |
| 00887517022035 | K181860 | 000 |
| 00887517022042 | K181860 | 000 |
| 00887517022059 | K181860 | 000 |
| 00887517022066 | K181860 | 000 |
| 00887517022073 | K181860 | 000 |
| 00887517022080 | K181860 | 000 |
| 00887517022097 | K181860 | 000 |
| 00887517022103 | K181860 | 000 |
| 00887517022028 | K181860 | 000 |
| 00887517022011 | K181860 | 000 |
| 00195377029539 | K181860 | 000 |
| 00195377029546 | K181860 | 000 |
| 00195377029577 | K181860 | 000 |
| 00195377029591 | K181860 | 000 |
| 00195377029607 | K181860 | 000 |
| 00887517017574 | K181860 | 000 |
| 00887517017581 | K181860 | 000 |
| 00887517022004 | K181860 | 000 |
| 00887517022110 | K181860 | 000 |
| 00887517022134 | K181860 | 000 |
| 00887517022141 | K181860 | 000 |
| 00887517983244 | K181860 | 000 |
| 00887517983305 | K181860 | 000 |
| 00887517983329 | K181860 | 000 |
| 00887517982667 | K181860 | 000 |
| 00887517982681 | K181860 | 000 |
| 00887517982742 | K181860 | 000 |
| 00887517982766 | K181860 | 000 |
| 00887517982827 | K181860 | 000 |
| 00887517983220 | K181860 | 000 |
| 00887517983169 | K181860 | 000 |
| 00887517022158 | K181860 | 000 |
| 00887517982186 | K181860 | 000 |
| 00887517982209 | K181860 | 000 |
| 00887517982261 | K181860 | 000 |
| 00887517982285 | K181860 | 000 |
| 00887517982346 | K181860 | 000 |
| 00887517982360 | K181860 | 000 |
| 00887517983145 | K181860 | 000 |
| 00887517982841 | K181860 | 000 |