K991398 is an FDA 510(k) clearance for the BONESOURCE HYDROXYAPATITE CEMENT (HAC) EXPANDED KIT. This device is classified as a Methyl Methacrylate For Cranioplasty (Class II - Special Controls, product code GXP).
Submitted by Stryker Leibinger (Kalamazoo, US). The FDA issued a Cleared decision on September 22, 1999, 153 days after receiving the submission on April 22, 1999.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 882.5300.
| 510(k) Number | K991398 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 22, 1999 |
| Decision Date | September 22, 1999 |
| Days to Decision | 153 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | GXP — Methyl Methacrylate For Cranioplasty |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5300 |