The following data is part of a premarket notification filed by Stryker with the FDA for Stryker Injectable Cement.
| Device ID | K060763 |
| 510k Number | K060763 |
| Device Name: | STRYKER INJECTABLE CEMENT |
| Classification | Methyl Methacrylate For Cranioplasty |
| Applicant | Stryker 750 TRADE CENTRE WAY STE 200 Portage, MI 49002 |
| Contact | Wade T Rutkoskie |
| Correspondent | Wade T Rutkoskie Stryker 750 TRADE CENTRE WAY STE 200 Portage, MI 49002 |
| Product Code | GXP |
| CFR Regulation Number | 882.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-03-21 |
| Decision Date | 2006-09-22 |
| Summary: | summary |