The following data is part of a premarket notification filed by Stryker Cmf with the FDA for Stryker Injectable Cement.
| Device ID | K060750 |
| 510k Number | K060750 |
| Device Name: | STRYKER INJECTABLE CEMENT |
| Classification | Cement, Ear, Nose And Throat |
| Applicant | STRYKER CMF 750 TRADE CENTRE WAY Kalamazoo, MI 49001 |
| Contact | Wade T Rutkoskie |
| Correspondent | Wade T Rutkoskie STRYKER CMF 750 TRADE CENTRE WAY Kalamazoo, MI 49001 |
| Product Code | NEA |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-03-21 |
| Decision Date | 2006-04-19 |
| Summary: | summary |