The following data is part of a premarket notification filed by Nuvasive, Inc. with the FDA for Nuvasive Long Lateral Spinal System.
Device ID | K111410 |
510k Number | K111410 |
Device Name: | NUVASIVE LONG LATERAL SPINAL SYSTEM |
Classification | Appliance, Fixation, Spinal Intervertebral Body |
Applicant | NUVASIVE, INC. 7475 LUSK BLVD San Diego, CA 92121 |
Contact | Elias Ketchum |
Correspondent | Elias Ketchum NUVASIVE, INC. 7475 LUSK BLVD San Diego, CA 92121 |
Product Code | KWQ |
CFR Regulation Number | 888.3060 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-05-19 |
Decision Date | 2011-06-20 |
Summary: | summary |