The following data is part of a premarket notification filed by Amedica Corp. with the FDA for Modification To: Vented Cement Restrictor, Model 60102-000-001/004.
| Device ID | K050699 |
| 510k Number | K050699 |
| Device Name: | MODIFICATION TO: VENTED CEMENT RESTRICTOR, MODEL 60102-000-001/004 |
| Classification | Prosthesis, Hip, Cement Restrictor |
| 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 | JDK |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-03-18 |
| Decision Date | 2005-04-15 |
| Summary: | summary |