The following data is part of a premarket notification filed by Stryker Leibinger Micro Implants with the FDA for Stryker Injectable Cement.
| Device ID | K051603 |
| 510k Number | K051603 |
| Device Name: | STRYKER INJECTABLE CEMENT |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | STRYKER LEIBINGER MICRO IMPLANTS 750 TRADE CENTRE WAY Portage, MI 49002 |
| Contact | Wade T Rutkoskie |
| Correspondent | Wade T Rutkoskie STRYKER LEIBINGER MICRO IMPLANTS 750 TRADE CENTRE WAY Portage, MI 49002 |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-06-15 |
| Decision Date | 2005-12-30 |
| Summary: | summary |