510(k) K251791
K251791 is an FDA 510(k) premarket notification submitted by Auxano Medical, LLC for the device "Auxano® Wedge Fixation System". The FDA issued a decision of Substantially Equivalent on September 25, 2025. The device falls under product code PLF (Bone Wedge), a Class II device regulated under 21 CFR 888.3030. Auxano Medical, LLC has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 25, 2025
- Date Received
- June 11, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Bone Wedge
- Device Class
- Class II
- Regulation Number
- 888.3030
- Review Panel
- OR
- Submission Type
Intended to be used with ancillary fixation for opening wedge osteotomies or fusion in the ankle, foot, proximal tibia.