K040369 is an FDA 510(k) clearance for the STRYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEM. This device is classified as a Driver, Wire, And Bone Drill, Manual (Class II - Special Controls, product code DZJ).
Submitted by Stryker Instruments (Kalamazoo, US). The FDA issued a Cleared decision on April 1, 2004, 48 days after receiving the submission on February 13, 2004.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4120.
| 510(k) Number | K040369 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 13, 2004 |
| Decision Date | April 01, 2004 |
| Days to Decision | 48 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | DZJ — Driver, Wire, And Bone Drill, Manual |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.4120 |