FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
External Fixation Bone Distractor
K Number: K251862
·
Decision Aug 11, 2025
Classifications
1
FEI Numbers
249
Registration Numbers
249
Same Product Code
403
Applicant Total
50
Review Days
55
Basic Information
- Device Name
- External Fixation Bone Distractor
- K Number
- K251862
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3030
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Paragon 28, Inc.
- Date Received
- June 17, 2025
- Decision Date
- August 11, 2025
- Product Code
- KTT
- 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 |
|---|---|---|---|
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | FDA class 2 | Orthopedic |
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