K003549 is an FDA 510(k) clearance for the CODMAN CRANIOSORB ABSORBABLE FIXATION SYSTEM PURPLE RIVETS. 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 February 15, 2001, 90 days after receiving the submission on November 17, 2000.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4760.
| 510(k) Number | K003549 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 17, 2000 |
| Decision Date | February 15, 2001 |
| 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 |