K221947 is an FDA 510(k) clearance for the Tyber Medical Staple Fixation System (various). This device is classified as a Staple, Fixation, Bone (Class II - Special Controls, product code JDR).
Submitted by Tyber Medical, LLC (Bethlehem, US). The FDA issued a Cleared decision on October 20, 2022, 107 days after receiving the submission on July 5, 2022.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3030.
| 510(k) Number | K221947 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 05, 2022 |
| Decision Date | October 20, 2022 |
| Days to Decision | 107 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | JDR — Staple, Fixation, Bone |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3030 |