The following data is part of a premarket notification filed by Amedica Corp. with the FDA for Modification To Valeo Vbr.
| Device ID | K073505 |
| 510k Number | K073505 |
| Device Name: | MODIFICATION TO VALEO VBR |
| Classification | Spinal Vertebral Body Replacement Device |
| Applicant | AMEDICA CORP. 1331 H ST. NW, 12TH FLOOR Washington, DC 20005 |
| Contact | Adam Herder |
| Correspondent | Adam Herder AMEDICA CORP. 1331 H ST. NW, 12TH FLOOR Washington, DC 20005 |
| Product Code | MQP |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-12-13 |
| Decision Date | 2008-01-09 |
| Summary: | summary |