The following data is part of a premarket notification filed by Nuvasive Incorporated with the FDA for Nuvasive X-core Expandable Vbr System, Nuvasive X-core Mini Cervical Expandable Vbr System.
| Device ID | K193506 |
| 510k Number | K193506 |
| Device Name: | NuVasive X-Core Expandable VBR System, NuVasive X-Core Mini Cervical Expandable VBR System |
| Classification | Spinal Vertebral Body Replacement Device |
| Applicant | NuVasive Incorporated 7475 Lusk Boulevard San Diego, CA 92121 |
| Contact | Aditya Sharma |
| Correspondent | Aditya Sharma NuVasive Incorporated 7475 Lusk Boulevard 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 | 2019-12-18 |
| Decision Date | 2020-02-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00887517684981 | K193506 | 000 |
| 00887517678126 | K193506 | 000 |
| 00887517678096 | K193506 | 000 |
| 00887517678027 | K193506 | 000 |
| 00887517678003 | K193506 | 000 |
| 00887517677952 | K193506 | 000 |
| 00887517677907 | K193506 | 000 |
| 00887517677891 | K193506 | 000 |
| 00887517677884 | K193506 | 000 |
| 00887517677877 | K193506 | 000 |
| 00887517677860 | K193506 | 000 |
| 00887517677853 | K193506 | 000 |
| 00887517677846 | K193506 | 000 |
| 00887517678225 | K193506 | 000 |
| 00887517678232 | K193506 | 000 |
| 00887517684974 | K193506 | 000 |
| 00887517684967 | K193506 | 000 |
| 00887517684950 | K193506 | 000 |
| 00887517684943 | K193506 | 000 |
| 00887517684936 | K193506 | 000 |
| 00887517678362 | K193506 | 000 |
| 00887517678355 | K193506 | 000 |
| 00887517678324 | K193506 | 000 |
| 00887517678300 | K193506 | 000 |
| 00887517678294 | K193506 | 000 |
| 00887517678256 | K193506 | 000 |
| 00887517678249 | K193506 | 000 |
| 00887517677839 | K193506 | 000 |