The following data is part of a premarket notification filed by Amedica Corp. with the FDA for Valeo C Spacer System, Valeo Ii C Ibf Device.
| Device ID | K142264 |
| 510k Number | K142264 |
| Device Name: | Valeo C Spacer System, Valeo II C IBF Device |
| Classification | Intervertebral Fusion Device With Bone Graft, Cervical |
| Applicant | Amedica Corp. 1885 West 2100 South Salt Lake City, UT 84119 |
| Contact | William D Jordan |
| Correspondent | Justin Eggleton MCRA, LLC 1331 H Street NW, 12th Floor Washington, DC 20005 |
| Product Code | ODP |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-08-15 |
| Decision Date | 2014-12-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841732144811 | K142264 | 000 |
| 00841732144682 | K142264 | 000 |
| 00841732144675 | K142264 | 000 |
| 00841732144668 | K142264 | 000 |
| 00841732144651 | K142264 | 000 |
| 00841732144613 | K142264 | 000 |
| 00841732144606 | K142264 | 000 |
| 00841732144590 | K142264 | 000 |
| 00841732144583 | K142264 | 000 |
| 00841732144576 | K142264 | 000 |
| 00841732144569 | K142264 | 000 |
| 00841732144552 | K142264 | 000 |
| 00841732144538 | K142264 | 000 |
| 00841732144514 | K142264 | 000 |
| 00841732144507 | K142264 | 000 |
| 00841732144699 | K142264 | 000 |
| 00841732144705 | K142264 | 000 |
| 00841732144712 | K142264 | 000 |
| 00841732144804 | K142264 | 000 |
| 00841732144460 | K142264 | 000 |
| 00841732144439 | K142264 | 000 |
| 00841732144415 | K142264 | 000 |
| 00841732144392 | K142264 | 000 |
| 00841732144354 | K142264 | 000 |
| 00841732144798 | K142264 | 000 |
| 00841732144781 | K142264 | 000 |
| 00841732144774 | K142264 | 000 |
| 00841732144767 | K142264 | 000 |
| 00841732144750 | K142264 | 000 |
| 00841732144743 | K142264 | 000 |
| 00841732144736 | K142264 | 000 |
| 00841732144729 | K142264 | 000 |
| 00841732144491 | K142264 | 000 |