The following data is part of a premarket notification filed by Nuvasive, Inc. with the FDA for Nuvasive Adjustable Vertebral Body Replacement System.
Device ID | K090176 |
510k Number | K090176 |
Device Name: | NUVASIVE ADJUSTABLE VERTEBRAL BODY REPLACEMENT SYSTEM |
Classification | Spinal Vertebral Body Replacement Device |
Applicant | NUVASIVE, INC. 7475 LUSK BLVD San Diego, CA 92121 |
Contact | Han Fan |
Correspondent | Han Fan NUVASIVE, INC. 7475 LUSK BLVD San Diego, CA 92121 |
Product Code | MQP |
CFR Regulation Number | 888.3060 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2009-01-23 |
Decision Date | 2009-04-27 |
Summary: | summary |