FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Pediatric Plating Platform I Small-Mini
K Number: K252600
·
Decision Oct 9, 2025
Classifications
1
FEI Numbers
519
Registration Numbers
519
Same Product Code
1313
Applicant Total
40
Review Days
52
Basic Information
- Device Name
- Pediatric Plating Platform I Small-Mini
- K Number
- K252600
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3030
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- OrthoPediatrics Corp.
- Date Received
- August 18, 2025
- Decision Date
- October 9, 2025
- 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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