K963394 is an FDA 510(k) clearance for the OSTEOMED TRAM. This device is classified as a Plate, Bone (Class II - Special Controls, product code JEY).
Submitted by Osteomed Corp. (Irving, US). The FDA issued a Cleared decision on November 14, 1996, 78 days after receiving the submission on August 28, 1996.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4760.
| 510(k) Number | K963394 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 28, 1996 |
| Decision Date | November 14, 1996 |
| Days to Decision | 78 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
| Product Code | JEY — Plate, Bone |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.4760 |