The following data is part of a premarket notification filed by Nuvasive, Incorporated with the FDA for Nuvasive® Coroent® Thoracolumbar System.
Device ID | K170962 |
510k Number | K170962 |
Device Name: | NuVasive® CoRoent® Thoracolumbar System |
Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
Applicant | NuVasive, Incorporated 7475 Lusk Blvd. San Diego, CA 92121 |
Contact | Marysa E. Loustalot |
Correspondent | Marysa E. Loustalot 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 | 2017-03-31 |
Decision Date | 2017-06-26 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
NUVASIVE 76298757 2818737 Live/Registered |
NUVASIVE, INC. 2001-08-10 |
NUVASIVE 75822001 2541247 Live/Registered |
NUVASIVE, INC. 1999-10-13 |