FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ORTHOFIX CONTOURS PROIMAL HUMERAL PLATE (PHP)
K Number: K122541
·
Decision Sep 20, 2012
Classifications
1
FEI Numbers
51
Registration Numbers
51
Same Product Code
37
Applicant Total
38
Review Days
30
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Basic Information
- Device Name
- ORTHOFIX CONTOURS PROIMAL HUMERAL PLATE (PHP)
- K Number
- K122541
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3030
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Orthofix Srl
- Date Received
- August 21, 2012
- Decision Date
- September 20, 2012
- Product Code
- KTW
- 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 |
|---|---|---|---|
| KTW | Appliance, Fixation, Nail/Blade/Plate Combination, Single Component | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KTW), ordered by most recent decision date.
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SYNTHES (USA) MODULAR BLADE PLATE SYSTEM
FDA 510(k)
FDA Class 2
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| K213572 | JuniOrtho Plating System | Jan 18, 2022 | Substantially Equivalent |
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