K213777 is an FDA 510(k) clearance for the Stryker Resorbable Fixation System. This device is classified as a Plate, Bone (Class II - Special Controls, product code JEY).
Submitted by Stryker Leibinger Micro Implants (Portage, US). The FDA issued a Cleared decision on February 4, 2022, 63 days after receiving the submission on December 3, 2021.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4760.
| 510(k) Number | K213777 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 03, 2021 |
| Decision Date | February 04, 2022 |
| Days to Decision | 63 days |
| Submission Type | Special |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | JEY — Plate, Bone |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.4760 |