K241357 is an FDA 510(k) clearance for the XT3 System. This device is classified as a Pin, Fixation, Threaded (Class II - Special Controls, product code JDW).
Submitted by Biodynamik, Inc. (Lake Forest, US). The FDA issued a Cleared decision on January 22, 2025, 253 days after receiving the submission on May 14, 2024.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3040.
| 510(k) Number | K241357 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 14, 2024 |
| Decision Date | January 22, 2025 |
| Days to Decision | 253 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | JDW - Pin, Fixation, Threaded |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3040 |