The following data is part of a premarket notification filed by Nuvasive, Incorporated with the FDA for Nuvasive® Reline® 4.5-5.0 System.
Device ID | K170126 |
510k Number | K170126 |
Device Name: | NuVasive® Reline® 4.5-5.0 System |
Classification | Thoracolumbosacral Pedicle Screw System |
Applicant | NUVASIVE, INCORPORATED 7475 LUSK BLVD. San Diego, CA 92121 |
Contact | Olga Lewis |
Correspondent | Olga Lewis NUVASIVE, INCORPORATED 7475 Lusk Boulevard San Diego, CA 92121 |
Product Code | NKB |
Subsequent Product Code | KWP |
Subsequent Product Code | KWQ |
CFR Regulation Number | 888.3070 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-01-13 |
Decision Date | 2017-03-09 |
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 |