The following data is part of a premarket notification filed by Nuvasive Incorporated with the FDA for Nuvasive Reline System.
Device ID | K143684 |
510k Number | K143684 |
Device Name: | NuVasive Reline System |
Classification | Thoracolumbosacral Pedicle Screw System |
Applicant | NUVASIVE INCORPORATED 7475 LUSK BOULEVARD 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 |
Subsequent Product Code | MNH |
Subsequent Product Code | MNI |
Subsequent Product Code | OSH |
CFR Regulation Number | 888.3070 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-12-24 |
Decision Date | 2015-04-23 |
Summary: | summary |