The following data is part of a premarket notification filed by Nuvasive, Incorporated with the FDA for Nuvasive X-core Mini Cervical Expandable Vbr System.
| Device ID | K151651 |
| 510k Number | K151651 |
| Device Name: | NuVasive X-CORE Mini Cervical Expandable VBR System |
| Classification | Spinal Vertebral Body Replacement Device - Cervical |
| Applicant | NUVASIVE, INCORPORATED 7475 LUSK BLVD. San Diego, CA 92121 |
| Contact | Olga Lewis |
| Correspondent | Olga Lewis NUVASIVE, INCORPORATED 7475 LUSK BLVD. San Diego, CA 92121 |
| Product Code | PLR |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-06-18 |
| Decision Date | 2015-09-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00887517426574 | K151651 | 000 |
| 00887517424600 | K151651 | 000 |
| 00887517425140 | K151651 | 000 |
| 00887517427847 | K151651 | 000 |
| 00887517434616 | K151651 | 000 |
| 00887517435477 | K151651 | 000 |
| 00887517206343 | K151651 | 000 |
| 00887517265845 | K151651 | 000 |
| 00887517267207 | K151651 | 000 |
| 00887517269331 | K151651 | 000 |
| 00887517267733 | K151651 | 000 |
| 00887517269348 | K151651 | 000 |
| 00887517308313 | K151651 | 000 |
| 00887517308320 | K151651 | 000 |
| 00887517677969 | K151651 | 000 |