K043334 is an FDA 510(k) clearance for the BONE SOURCE HAC RAPID SETTING CEMENT. This device is classified as a Methyl Methacrylate For Cranioplasty (Class II - Special Controls, product code GXP).
Submitted by Stryker Instruments (Kalamazoo, US). The FDA issued a Cleared decision on February 9, 2005, 68 days after receiving the submission on December 3, 2004.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 882.5300.
| 510(k) Number | K043334 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 03, 2004 |
| Decision Date | February 09, 2005 |
| Days to Decision | 68 days |
| Submission Type | Special |
| 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 |