K944565 is an FDA 510(k) clearance for the KLS-MARTIN MICRO OSTEOSYTHESIS SYSTEM(1.5MM). This device is classified as a Plate, Bone (Class II - Special Controls, product code JEY).
Submitted by KLS-Martin L.P. (Washington, US). The FDA issued a Cleared decision on October 18, 1994, 32 days after receiving the submission on September 16, 1994.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4760.
| 510(k) Number | K944565 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 16, 1994 |
| Decision Date | October 18, 1994 |
| Days to Decision | 32 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 |