FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PTA (PROGRESSIVE TIBIAL ALIGNMENT)
K Number: K060403
·
Decision Mar 28, 2006
Classifications
1
FEI Numbers
101
Registration Numbers
101
Same Product Code
56
Applicant Total
1
Review Days
41
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Basic Information
- Device Name
- PTA (PROGRESSIVE TIBIAL ALIGNMENT)
- K Number
- K060403
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3030
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Meridian Medical
- Date Received
- February 15, 2006
- Decision Date
- March 28, 2006
- Product Code
- LXT
- 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 |
|---|---|---|---|
| LXT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite | FDA class 2 | Orthopedic |
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