The following data is part of a premarket notification filed by Amedica Corp. with the FDA for Vented Cement Restrictor.
| Device ID | K022729 |
| 510k Number | K022729 |
| Device Name: | VENTED CEMENT RESTRICTOR |
| Classification | Instrument, Surgical, Sonic And Accessory/attachment |
| Applicant | AMEDICA CORP. 2116 SOUTH LAKELINE DR. Salt Lake City, UT 84109 |
| Contact | Ashok C Khandkar |
| Correspondent | Ashok C Khandkar AMEDICA CORP. 2116 SOUTH LAKELINE DR. Salt Lake City, UT 84109 |
| Product Code | JDX |
| CFR Regulation Number | 888.4580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-08-16 |
| Decision Date | 2002-11-14 |
| Summary: | summary |