K012569 is an FDA 510(k) clearance for the MODIFICATION TO: INJECTABLE MIMIX. This device is classified as a Methyl Methacrylate For Cranioplasty (Class II - Special Controls, product code GXP).
Submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on December 21, 2001, 134 days after receiving the submission on August 9, 2001.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5300.
| 510(k) Number | K012569 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 09, 2001 |
| Decision Date | December 21, 2001 |
| Days to Decision | 134 days |
| Submission Type | Special |
| 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 |