FDA 510(k)
FDA class 2
Substantially Equivalent
🇦🇺 Australia
SMART Osteotomy System
K Number: K260090
·
Decision Apr 10, 2026
Classifications
1
FEI Numbers
519
Registration Numbers
519
Same Product Code
1313
Applicant Total
1
Review Days
88
Basic Information
- Device Name
- SMART Osteotomy System
- K Number
- K260090
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3030
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Actis Medical Pty., Ltd.
- Date Received
- January 12, 2026
- Decision Date
- April 10, 2026
- Product Code
- HRS
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| HRS | Plate, Fixation, Bone | FDA class 2 | Orthopedic |
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