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 |