FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Monkey Bars Pin to Bar External Fixation System
K Number: K242452
·
Decision Nov 1, 2024
Classifications
1
FEI Numbers
247
Registration Numbers
247
Same Product Code
392
Applicant Total
34
Review Days
74
Basic Information
- Device Name
- Monkey Bars Pin to Bar External Fixation System
- K Number
- K242452
- 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
- August 19, 2024
- Decision Date
- November 1, 2024
- 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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