FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Total Wrist Arthroplasty System (TWA)
K Number: K243381
·
Decision Nov 1, 2024
Classifications
1
FEI Numbers
37
Registration Numbers
37
Same Product Code
16
Applicant Total
20
Review Days
2
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Basic Information
- Device Name
- Total Wrist Arthroplasty System (TWA)
- K Number
- K243381
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3800
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Skeletal Dynamics, Inc.
- Date Received
- October 30, 2024
- Decision Date
- November 1, 2024
- 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
Freedom Wrist Arthroplasty System
FDA 510(k)
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Arthrosurface WristMotion Total Wrist Arthroplasty System
FDA 510(k)
FDA Class 2
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KinematX 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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