FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
INTEGRA FREEDOM WRIST ARTHROPLASTY SYSTEM
K Number: K132250
·
Decision Mar 24, 2014
Classifications
1
FEI Numbers
37
Registration Numbers
37
Same Product Code
16
Applicant Total
65
Review Days
248
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Basic Information
- Device Name
- INTEGRA FREEDOM WRIST ARTHROPLASTY SYSTEM
- K Number
- K132250
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3800
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Integra LifeSciences Corporation
- Date Received
- July 19, 2013
- Decision Date
- March 24, 2014
- Product Code
- JWJ
- 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 |
|---|---|---|---|
| JWJ | Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
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