K241357
- 510(k) number
- K241357
- Device name
- XT3 System
- Applicant
- Biodynamik, Inc. CA · US
- Product code
- JDW — Pin, Fixation, Threaded
- Decision date
- 2025-01-22
- Date received
- 2024-05-14
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 1.4 MB · U.S. public domain
Also available from FDA: K241357.pdf
Official FDA record: K241357
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.