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 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841732129740 | K073505 | 000 |
| 00841732128903 | K073505 | 000 |
| 00841732128897 | K073505 | 000 |
| 00841732128880 | K073505 | 000 |
| 00841732128873 | K073505 | 000 |
| 00841732128866 | K073505 | 000 |
| 00841732128859 | K073505 | 000 |
| 00841732128842 | K073505 | 000 |
| 00841732128835 | K073505 | 000 |
| 00841732128828 | K073505 | 000 |
| 00841732128811 | K073505 | 000 |
| 00841732128804 | K073505 | 000 |
| 00841732128798 | K073505 | 000 |
| 00841732128781 | K073505 | 000 |
| 00841732128774 | K073505 | 000 |
| 00841732128767 | K073505 | 000 |
| 00841732128750 | K073505 | 000 |
| 00841732128743 | K073505 | 000 |
| 00841732128910 | K073505 | 000 |
| 00841732128927 | K073505 | 000 |
| 00841732129092 | K073505 | 000 |
| 00841732129085 | K073505 | 000 |
| 00841732129078 | K073505 | 000 |
| 00841732129061 | K073505 | 000 |
| 00841732129054 | K073505 | 000 |
| 00841732129047 | K073505 | 000 |
| 00841732129030 | K073505 | 000 |
| 00841732129023 | K073505 | 000 |
| 00841732129016 | K073505 | 000 |
| 00841732129009 | K073505 | 000 |
| 00841732128996 | K073505 | 000 |
| 00841732128989 | K073505 | 000 |
| 00841732128972 | K073505 | 000 |
| 00841732128965 | K073505 | 000 |
| 00841732128958 | K073505 | 000 |
| 00841732128941 | K073505 | 000 |
| 00841732128934 | K073505 | 000 |
| 00841732128736 | K073505 | 000 |