The following data is part of a premarket notification filed by Stryker Corp. with the FDA for Stryker Injectable Cement.
| Device ID | K060061 |
| 510k Number | K060061 |
| Device Name: | STRYKER INJECTABLE CEMENT |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | STRYKER CORP. 750 TRADE CENTRE WAY SUITE 200 Kalamazoo, MI 49001 |
| Contact | Wade T Rutkoskie |
| Correspondent | Wade T Rutkoskie STRYKER CORP. 750 TRADE CENTRE WAY SUITE 200 Kalamazoo, MI 49001 |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-01-09 |
| Decision Date | 2006-03-01 |
| Summary: | summary |