The following data is part of a premarket notification filed by Nuvasive, Inc. with the FDA for Gsb Global Spinal Balance System.
Device ID | K132014 |
510k Number | K132014 |
Device Name: | GSB GLOBAL SPINAL BALANCE SYSTEM |
Classification | Thoracolumbosacral Pedicle Screw System |
Applicant | NUVASIVE, INC. 7475 LUSK BLVD San Diego, CA 92121 |
Contact | Olga Lewis |
Correspondent | Olga Lewis NUVASIVE, INC. 7475 LUSK BLVD San Diego, CA 92121 |
Product Code | NKB |
Subsequent Product Code | KWP |
Subsequent Product Code | KWQ |
Subsequent Product Code | MNH |
Subsequent Product Code | MNI |
CFR Regulation Number | 888.3070 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-07-01 |
Decision Date | 2013-10-31 |
Summary: | summary |