K012486 is an FDA 510(k) clearance for the OSTEOMED BIORESORBABLE FIXATION SYSTEM. This device is classified as a Screw, Fixation, Intraosseous (Class II - Special Controls, product code DZL).
Submitted by Osteomed Corp. (Addison, US). The FDA issued a Cleared decision on January 16, 2002, 167 days after receiving the submission on August 2, 2001.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4880.
| 510(k) Number | K012486 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 02, 2001 |
| Decision Date | January 16, 2002 |
| Days to Decision | 167 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | DZL — Screw, Fixation, Intraosseous |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.4880 |