K101902 is an FDA 510(k) clearance for the J TAC MODEL JT-MD-035, JT-MD-040, JT-MD-045, JT-CL-030. This device is classified as a Screw, Fixation, Intraosseous (Class II - Special Controls, product code DZL).
Submitted by Jeil Medical Corporation (Marietta, US). The FDA issued a Cleared decision on February 8, 2011, 215 days after receiving the submission on July 8, 2010.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4880.
| 510(k) Number | K101902 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 08, 2010 |
| Decision Date | February 08, 2011 |
| Days to Decision | 215 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 |