The following data is part of a premarket notification filed by Amedica Corp. with the FDA for Seeplate Cervical Plate System.
| Device ID | K082037 |
| 510k Number | K082037 |
| Device Name: | SEEPLATE CERVICAL PLATE SYSTEM |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| 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 | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-07-17 |
| Decision Date | 2008-09-26 |
| Summary: | summary |