K002798 is an FDA 510(k) clearance for the CODMAN CRANIOSORB ABSORBABLE FIXATION SYSTEM DRILL BITS. This device is classified as a Plate, Bone (Class II - Special Controls, product code JEY).
Submitted by Codman & Shurtleff, Inc. (Raynham, US). The FDA issued a Cleared decision on December 6, 2000, 90 days after receiving the submission on September 7, 2000.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4760.
| 510(k) Number | K002798 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 07, 2000 |
| Decision Date | December 06, 2000 |
| Days to Decision | 90 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 |