K961418 is an FDA 510(k) clearance for the OSTEOMED MSS. This device is classified as a Screw, Fixation, Intraosseous (Class II - Special Controls, product code DZL).
Submitted by Osteomed Corp. (Irving, US). The FDA issued a Cleared decision on October 25, 1996, 196 days after receiving the submission on April 12, 1996.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4880.
| 510(k) Number | K961418 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 12, 1996 |
| Decision Date | October 25, 1996 |
| Days to Decision | 196 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 |