The following data is part of a premarket notification filed by Nuvasive, Incorporated with the FDA for Lateral Vbr System.
| Device ID | K140563 |
| 510k Number | K140563 |
| Device Name: | LATERAL VBR SYSTEM |
| Classification | Spinal Vertebral Body Replacement Device |
| Applicant | NUVASIVE, INCORPORATED 7475 LUSK BLVD San Diego, CA 92121 |
| Contact | Jeremy Markovich |
| Correspondent | Jeremy Markovich NUVASIVE, INCORPORATED 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 | 2014-03-05 |
| Decision Date | 2014-08-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00887517497901 | K140563 | 000 |
| 00887517497895 | K140563 | 000 |
| 00887517497888 | K140563 | 000 |
| 00887517497871 | K140563 | 000 |
| 00887517497864 | K140563 | 000 |
| 00887517497857 | K140563 | 000 |
| 00887517497840 | K140563 | 000 |
| 00887517497833 | K140563 | 000 |
| 00887517497826 | K140563 | 000 |