The following data is part of a premarket notification filed by Nuvasive, Inc. with the FDA for Nuvasive X-core(r) Expandable Vbr System.
| Device ID | K142205 |
| 510k Number | K142205 |
| Device Name: | NuVasive X-CORE(R) Expandable VBR System |
| Classification | Spinal Vertebral Body Replacement Device |
| 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 | MQP |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-08-11 |
| Decision Date | 2015-02-20 |
| Summary: | summary |