The following data is part of a premarket notification filed by Nuvasive, Incorporated with the FDA for Nuvasive Brigade Lateral System.
Device ID | K181386 |
510k Number | K181386 |
Device Name: | NuVasive Brigade Lateral System |
Classification | Intervertebral Fusion Device With Integrated Fixation, Lumbar |
Applicant | NuVasive, Incorporated 7475 Lusk Blvd. San Diego, CA 92121 |
Contact | Jessica Silverman |
Correspondent | Jessica Silverman NuVasive, Incorporated 7475 Lusk Blvd. San Diego, CA 92121 |
Product Code | OVD |
CFR Regulation Number | 888.3080 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2018-05-25 |
Decision Date | 2018-08-24 |