The following data is part of a premarket notification filed by Nuvasive, Inc. with the FDA for Nuvasive Vuepoint Oct System.
Device ID | K093319 |
510k Number | K093319 |
Device Name: | NUVASIVE VUEPOINT OCT SYSTEM |
Classification | Appliance, Fixation, Spinal Interlaminal |
Applicant | NUVASIVE, INC. 7475 LUSK BLVD San Diego, CA 92121 |
Contact | Sheila Bruschi |
Correspondent | Sheila Bruschi NUVASIVE, INC. 7475 LUSK BLVD San Diego, CA 92121 |
Product Code | KWP |
CFR Regulation Number | 888.3050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2009-10-23 |
Decision Date | 2010-06-23 |
Summary: | summary |