K040152 is an FDA 510(k) clearance for the BONE CEMENT FOR CRANIOPLASTY. This device is classified as a Methyl Methacrylate For Cranioplasty (Class II - Special Controls, product code GXP).
Submitted by Cardinalhealth (Mcgaw Park, US). The FDA issued a Cleared decision on May 19, 2004, 117 days after receiving the submission on January 23, 2004.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5300.
| 510(k) Number | K040152 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 23, 2004 |
| Decision Date | May 19, 2004 |
| Days to Decision | 117 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | GXP — Methyl Methacrylate For Cranioplasty |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5300 |