510(k) K250472
K250472 is an FDA 510(k) premarket notification submitted by Amdt Holdings, Inc. for the device "SixFix Hexapod Fixator and Deformity Analysis and Correction Software (DACS)". The FDA issued a decision of Substantially Equivalent on August 8, 2025. The device falls under product code KTT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component), a Class II device regulated under 21 CFR 888.3030.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 8, 2025
- Date Received
- February 18, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
- Device Class
- Class II
- Regulation Number
- 888.3030
- Review Panel
- OR
- Submission Type