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 |