The following data is part of a premarket notification filed by Stryker Instruments with the FDA for Bone Source Hac Rapid Setting Cement.
| Device ID | K043334 |
| 510k Number | K043334 |
| Device Name: | BONE SOURCE HAC RAPID SETTING CEMENT |
| Classification | Methyl Methacrylate For Cranioplasty |
| Applicant | STRYKER INSTRUMENTS 4100 EAST MILHAM AVE. Kalamazoo, MI 49001 |
| Contact | Wade T Rutkoskie |
| Correspondent | Wade T Rutkoskie STRYKER INSTRUMENTS 4100 EAST MILHAM AVE. Kalamazoo, MI 49001 |
| Product Code | GXP |
| CFR Regulation Number | 882.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-12-03 |
| Decision Date | 2005-02-09 |
| Summary: | summary |