The following data is part of a premarket notification filed by Stryker Leibinger with the FDA for Bonesource Hydroxyapatite Cement (hac) Expanded Kit.
| Device ID | K991398 |
| 510k Number | K991398 |
| Device Name: | BONESOURCE HYDROXYAPATITE CEMENT (HAC) EXPANDED KIT |
| Classification | Methyl Methacrylate For Cranioplasty |
| Applicant | STRYKER LEIBINGER 4100 EAST MILHAM AVE. Kalamazoo, MI 49001 |
| Contact | Kristyn R Kelley |
| Correspondent | Kristyn R Kelley STRYKER LEIBINGER 4100 EAST MILHAM AVE. Kalamazoo, MI 49001 |
| Product Code | GXP |
| CFR Regulation Number | 882.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-04-22 |
| Decision Date | 1999-09-22 |
| Summary: | summary |