The following data is part of a premarket notification filed by Amedica Corp. with the FDA for Arx Spinal System.
| Device ID | K051525 |
| 510k Number | K051525 |
| Device Name: | ARX SPINAL SYSTEM |
| Classification | Spinal Vertebral Body Replacement Device |
| Applicant | AMEDICA CORP. 615 ARAPEEN DRIVE Salt Lake City, UT 84108 |
| Contact | Robert M Wolfarth |
| Correspondent | Robert M Wolfarth AMEDICA CORP. 615 ARAPEEN DRIVE Salt Lake City, UT 84108 |
| Product Code | MQP |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-06-08 |
| Decision Date | 2006-02-17 |
| Summary: | summary |