The following data is part of a premarket notification filed by Amedica Corp. with the FDA for Valeo Vbr.
| Device ID | K073125 |
| 510k Number | K073125 |
| Device Name: | 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 | 2007-11-06 |
| Decision Date | 2007-12-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841732144941 | K073125 | 000 |
| 00841732155190 | K073125 | 000 |
| 00841732155183 | K073125 | 000 |
| 00841732155176 | K073125 | 000 |
| 00841732155169 | K073125 | 000 |
| 00841732155138 | K073125 | 000 |
| 00841732155121 | K073125 | 000 |
| 00841732155114 | K073125 | 000 |
| 00841732155107 | K073125 | 000 |
| 00841732155084 | K073125 | 000 |
| 00841732155077 | K073125 | 000 |
| 00841732155060 | K073125 | 000 |
| 00841732155053 | K073125 | 000 |
| 00841732155022 | K073125 | 000 |
| 00841732155206 | K073125 | 000 |
| 00841732155213 | K073125 | 000 |
| 00841732155220 | K073125 | 000 |
| 00841732144934 | K073125 | 000 |
| 00841732144927 | K073125 | 000 |
| 00841732144910 | K073125 | 000 |
| 00841732144897 | K073125 | 000 |
| 00841732144880 | K073125 | 000 |
| 00841732144873 | K073125 | 000 |
| 00841732144866 | K073125 | 000 |
| 00841732155824 | K073125 | 000 |
| 00841732155817 | K073125 | 000 |
| 00841732140851 | K073125 | 000 |
| 00841732155251 | K073125 | 000 |
| 00841732155244 | K073125 | 000 |
| 00841732155237 | K073125 | 000 |
| 00841732155015 | K073125 | 000 |