The following data is part of a premarket notification filed by Amedica Corp. with the FDA for Valeo Ii Interbody Fusion Device System.
| Device ID | K161405 |
| 510k Number | K161405 |
| Device Name: | Valeo II Interbody Fusion Device System |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-05-20 |
| Decision Date | 2016-08-19 |
| Summary: | summary |