K093719 is an FDA 510(k) clearance for the PRO-FIX PRECISION FIXATION SYSTEM MODEL PFM#, PFB#, PFT#. This device is classified as a Screw, Fixation, Intraosseous (Class II - Special Controls, product code DZL).
Submitted by Osteogenics Biomedical, Inc. (Lubbock, US). The FDA issued a Cleared decision on March 1, 2010, 89 days after receiving the submission on December 2, 2009.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4880.
| 510(k) Number | K093719 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 02, 2009 |
| Decision Date | March 01, 2010 |
| Days to Decision | 89 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
| Product Code | DZL — Screw, Fixation, Intraosseous |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.4880 |