K984230 is an FDA 510(k) clearance for the OSTEO-MESH TM-300. This device is classified as a Plate, Bone (Class II - Special Controls, product code JEY).
Submitted by Osteogenics Biomedical, Inc. (Fort Worth, US). The FDA issued a Cleared decision on February 4, 1999, 71 days after receiving the submission on November 25, 1998.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4760.
| 510(k) Number | K984230 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 25, 1998 |
| Decision Date | February 04, 1999 |
| Days to Decision | 71 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | JEY - Plate, Bone |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.4760 |