FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
KinematX Total Wrist Arthroplasty System
K Number: K191525
·
Decision Mar 4, 2020
Classifications
1
FEI Numbers
37
Registration Numbers
37
Same Product Code
16
Applicant Total
28
Review Days
268
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Basic Information
- Device Name
- KinematX Total Wrist Arthroplasty System
- K Number
- K191525
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3800
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Extremity Medical, LLC
- Date Received
- June 10, 2019
- Decision Date
- March 4, 2020
- 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
Other 510(k) clearances with the same product code (JWJ), ordered by most recent decision date.
Total Wrist Arthroplasty System (TWA)
FDA 510(k)
FDA Class 2
·Orthopedic
Total Wrist Arthroplasty System (TWA)
FDA 510(k)
FDA Class 2
·Orthopedic
Freedom Wrist Arthroplasty System
FDA 510(k)
FDA Class 2
·Orthopedic
Arthrosurface WristMotion Total Wrist Arthroplasty System
FDA 510(k)
FDA Class 2
·Orthopedic
INTEGRA FREEDOM WRIST ARTHROPLASTY SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
MAESTRO WRIST FRACTURE IMPLANT
FDA 510(k)
FDA Class 2
·Orthopedic
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