FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
A.L.P.S. Small Fragment Plating System
K Number: K243761
·
Decision Feb 19, 2025
Classifications
1
FEI Numbers
519
Registration Numbers
519
Same Product Code
1313
Applicant Total
4
Review Days
75
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Basic Information
- Device Name
- A.L.P.S. Small Fragment Plating System
- K Number
- K243761
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3030
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Biomet Orthopedics
- Date Received
- December 6, 2024
- Decision Date
- February 19, 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 |
Similar 510(k) Clearances
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