510(k) K260073
K260073 is an FDA 510(k) premarket notification submitted by Biodynamik, Inc. for the device "XT3 System; XT3 System, Mini; XT3 System, 40mm; XT3 System, Mini, 40mm". The FDA issued a decision of Substantially Equivalent on February 10, 2026. The device falls under product code JDW (Pin, Fixation, Threaded), a Class II device regulated under 21 CFR 888.3040. Biodynamik, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 10, 2026
- Date Received
- January 9, 2026
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Pin, Fixation, Threaded
- Device Class
- Class II
- Regulation Number
- 888.3040
- Review Panel
- OR
- Submission Type