510(k) K260090
K260090 is an FDA 510(k) premarket notification submitted by Actis Medical Pty., Ltd. for the device "SMART Osteotomy System". The FDA issued a decision of Substantially Equivalent on April 10, 2026. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 10, 2026
- Date Received
- January 12, 2026
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Plate, Fixation, Bone
- Device Class
- Class II
- Regulation Number
- 888.3030
- Review Panel
- OR
- Submission Type