The following data is part of a premarket notification filed by Amedica Corp with the FDA for Amedica Valeo Ii Interbody Fusion Device.
| Device ID | K142347 |
| 510k Number | K142347 |
| Device Name: | Amedica Valeo II Interbody Fusion Device |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | Amedica Corp 1885 West 2100 South Salt Lake City, UT 84119 |
| Contact | William D Jordan |
| Correspondent | William D Jordan Amedica Corp 1885 West 2100 South Salt Lake City, UT 84119 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-08-22 |
| Decision Date | 2014-11-18 |
| Summary: | summary |